Violation Code translation
Revised: 03-Feb-2009 07:49 AM
Reason: ***
Section: 402(a)(5), 801(a)(3); ADULTERATION
Charge: The food appears to be, in whole or in part, the
product of a diseased animal or of an animal which has died
otherwise than be slaughter.
Reason: ADDED BULK
Section: 402(b)(4), 801(a)(3); ADULTERATION
Charge: The food appears to have a substance added to, mixed
or packed with it so as to increase its bulk or weight, or
reduce its quality or strength, or make it appear better or
of greater value than it is.
Reason: AFLATOXIN
Section: 402(a)(1), 801(a)(3); ADULTERATION
Charge: The article appears to contain a mycotoxin, a
poisonous and deleterious substance which may render it
injurious to health.
Reason: AGR RX
Section: 801(d)(1),(2); IMPORTATION RESTRICTED
Charge: The article appears to be a prescription drug
manufactured in the U.S. and offered for import by other
than the manufacturer and reimportation does not appear to
have been authorized by the Secretary for use in a medical
Reason: AGRINSULIN
Section: 801(d)(1),(2);IMPORTATION RESTRICTED
Charge: The article appears to be composed wholly or partly
of insulin manufactured in the US and offered for import by
other than the manufacturer and reimportation does not
appear to have been authorized by the Secretary for a
Reason: ALCOHOL
Section: 402(d)(2), 801(a)(3); ADULTERATION
Charge: The article appears to be a confectionary that bears
or contains alcohol in excess of 1/2 of 1% by volume derived
solely from the use of flavoring extracts.
Reason: ALLERGEN
Section: 403(w) 801(a)(3); Misbranding
Charge: the label fails to declare all major food allergens
present in the product, as required by section 403(w)(1).
Reason: ANDRO
Section: 402(f)(1)(B),801(a)(3);ADULTERATION
Charge: The article is subject to refusal of admission
pursuant to section 801(a)(3) in that it appears to declare
and/or contain androstenedione, a new dietary ingredient for
which there is inadequate information to provide reasonable
Reason: ANTIBIOTIC
Section: 502(l), 801(a)(3); MISBRANDING
Charge: The drug appears to purport, or represented as,
being composed wholly or partly of an antibiotic and it does
not appear to be from a batch with respect to which a
certificate or release has been issued pursuant to section
Reason: BACTERIA
Section: 402(a)(1), 801(a)(3); ADULTERATION
Charge: The article appears to contain a poisonous and
deleterious substance which may render it injurious to
health. Contains
Reason: BANNED
Section: 501(g), 801(a)(3); ADULTERATION
Charge: The article appears to be a banned device.
Reason: BIO TOXIN
Section: 402(a)(1), 801(a)(3), Adulteration
Charge: The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to contain
a poisonous and deleterious substance which would ordinarily
render it injurious to health. Appears to contain
Reason: BIO TOXIN
Section: 801
Charge:
Reason: BSE DRUGS
Section: 501(a)(2)(A), 801(a)(1); Adulteration
Charge: The article is subject to refusal of admission
pursuant to Section 801(a)(1) in that it appears to have
been prepared, packed or held under insanitary conditions
whereby it may have been rendered injurious to health.
Reason: BSE FILTH
Section: 402(a)(3), 801(a)(3); Adulteration
Charge: The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to be unfit
for food.
Reason: BUTTER
Section: 402(e), 801(a)(3); ADULTERATION
Charge: The article appears to be oleo/margarine or butter
with raw materials consisting in whole or in part of a
filthy, putrid, or decomposed substance or the article is
otherwise be unfit for food.
Reason: CALIBRATED
Section: 502(f)(1); 801(a)(3), misbranding
Charge: The article is subject to refusal in that it is
calibrated in units not commonly used in the United States
Reason: CHLORAMP
Section: 402(a)(2)(C)(i), 801(a)(3); ADULTERATION
Charge: The article appears to contain a food additive,
namely chloramphenicol, that is unsafe within the meaning of
21 U.S.C. 348.
Reason: COL ADDED
Section: 501(a)(4)(A), 801(a)(3); ADULTERATION
Charge: The article appears to bear or contain, for the
purpose of coloring only, a color additive which is unsafe
within the meaning of Section 721(a).
Reason: COLOR
Section: 601%
Charge:
Reason: COLOR LBLG
Section: 602(e), 801(a)(3); MISBRANDING
Charge: The color additive appears to not have its packaging
and labeling in conformity with such requirements as issued
under section 721.
Reason: COLOR LBLG
Section: 403(k), 801(a)(3); MISBRANDING
Charge: The article appears to contain an artificial
coloring and it fails to bear labeling stating that fact.
Reason: CONCEALED
Section: 402(b)(3), 801(a)(3); ADULTERATION
Charge: It appears to be food which has damage or
inferiority concealed in any manner.
Reason: CONTAINER
Section: 501(a)(3), 801(a)(3); ADULTERATION
Charge: The container appears to be composed, in whole or in
part, of a poisonous or deleterious substance which may
render the contents injurious to health.
Reason: CONTAINER
Section: 601(d), 801(a)(3); ADULTERATION
Charge: The container appears to be composed, in whole or in
part, of a poisonous or deleterious substance which may
render the contents injurious to health.
Reason: CONTAINER
Section: 402(a)(6), 801(a)(3); ADULTERATION
Charge: The container appears to be composed, in whole or in
part, of a poisonous or deleterious substance which may
render the contents injurious to health.
Reason: CONTAM CAN
Section: 402(a)(1), 801(a)(3); ADULTERATION
Charge: The article appears to be held in a container
containing a poisonous or deleterious substance which may
render it injurious to health.
Reason: COSM COLOR
Section: 601(e), 801(a)(3); ADULTERATION
Charge: The cosmetic appears to not be a hair dye, and is,
bears, or contains a color additive which is unsafe within
the meaning of section 721(a).
Reason: COSM MISB
Section: 602(a) & 801(a)(3); MISBRANDING
Charge: The cosmetic's labeling appears to be false or
misleading within the meaning of Section 201(n).
Reason: COSM MISB2
Section: 602(a) & 801(a)(3); MISBRANDING
Charge: The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears that its
labeling is false or misleading in any particular
[Misbranding, Section 602(a)].
Reason: COSMETIC
Section: 601(c), 801(a)(3); Adulteration
Charge: The article appears to be an ingredient in a
cosmetic product and may have been prepared packed or held
under insanitary conditions whereby it may have become
contaminated with filth or rendered injurious to health.
Reason: COSMETLBLG
Section: 5(c)(3)(B); 801(a)(3) Misbranding
Charge: It appears that the cosmetic consists of two or more
ingredients and the label does not list the common or usual
name of each ingredient.
Reason: COSMETLBLG
Section: 5(c)(3)(A); 801(a)(3) Misbranding
Charge: It appears the label does not bear the common or
usual name of the cosmetic.
Reason: COUMARIN
Section: 402(a)(1), 801(a)(3), Adulteration
Charge: The article appears to bear or contain Coumarin, a
poisonous or deleterious substance, which may render it
injurious to health.
Reason: CSTIC LBLG
Section: 602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING
Charge: The labeling appears to fail to comply with cosmetic
labeling requirements of Section 602(a), and/or (b), and/or
(c), and as identified by 21 C.F.R. Part 701.
Reason: CYCLAMATE
Section: 402(a)(2)(C); 801(a)(3)
Charge: The article appears to bear or contain cyclamate, an
unsafe food additive within the meaning of Section 409
Reason: DANGEROUS
Section: 502(j), 801(a)(3); MISBRANDING
Charge: The article appears to be dangerous to health when
used in the dosage or manner, or with the frequency or
duration, prescribed, recommended, or suggested in the
labeling thereof.
Reason: DE IMP GMP
Section: 801(a)(1); NON CONFORMING MANUFACTURING PRACTICES
Charge: The methods used in, or the facilities or controls
used for the manufacture, packing, storage or installation
do not conform to the requirements under section 520(f).
Reason: DE/RX KIT
Section: 801(d)(1),(2); IMPORTATION RESTRICTED
Charge: The article appears to be a combination medical
device/prescription drug kit for which the prescription drug
component was manufactured in the U.S., is offered for
import by other than the manufacturer, and reimportation
Reason: DEVICE GMP
Section: 501(h), 801(a)(3); ADULTERATION
Charge: The methods, facilities, or controls used for the
article's manufacture, packing, storage. or installation do
not conform with applicable requirements under section
520(f)(1) or a condition prescribed by an order under
Reason: DEVICEGMPS
Section: 501(h), 801(a)(1); ADULTERATION
Charge: The methods, facilities, or controls used for the
article's manufacture, packing, storage, or installation do
not conform with applicable requirements under section
520(f)(1) or a condition prescribed by an order under
Reason: DEVNOEXPT
Section: 501(i), 801(a)(3)
Charge:
Reason: DIET INGRE
Section: 402(a)(3), 801(a)(3); Adulteration
Charge: The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to be for
use as an ingredient in a dietary supplement and appears to
be or may be otherwise unfit for food.
Reason: DIETARY
Section: 403(j), 801(a)(3); MISBRANDING
Charge: The article purports to be or is represented for
special dietary uses and its label does not appear to bear
the nutritional information required by regulation.
Reason: DIETARYLBL
Section: 403(s)(2)(B), 801(a)(3), misbranded
Charge: The label/labeling of the dietary supplement fails
to identify the product by using the term "dietary
supplement".
Reason: DIOXIN
Section: 402(a)(1),402(a)(2)(A),402(a)(2)(C)(i),801(a)(3)-Adulterated
Charge: The article appears to bear or contain dioxins
and/or PCB compounds, poisonous or deleterious substances
and/or unapproved food additives which may render it
injurious to health.
Reason: DIRECTIONS
Section: 502(f)(1), 801(a)(3); MISBRANDING
Charge: The article appears to lack adequate directions for
use.
Reason: DIRSEXMPT
Section: 502(f)(1), 801(a)(3); MISBRANDING
Charge: The article appears to lack adequate directions for
use, and the article does not appear to be exempt from such
requirements.
Reason: DISEASED
Section: 402(a)(5), 801(a)(3); ADULTERATION
Charge: The food appears to be, in whole or in part, the
product of a diseased animal or of an animal which has died
otherwise than by slaughter.
Reason: DR QUALITC
Section: 501(c), 801(a)(3); ADULTERATION
Charge: The drug appears to be represented as not being
recognized in an official compendium and appears its
strength differs from or its quality or purity falls below,
that which it purports or is represented to possess.
Reason: DR QUALITY
Section: 501(b), 801(a)(3); ADULTERATION
Charge: The article appears to be represented as a drug the
name of which is recognized in an official compendium and
its strength appears to differ from or its quality or purity
appear to fall below the standards set forth in such
Reason: DR QUALITY
Section: 501b
Charge:
Reason: DRUG COLOR
Section: 502(m), 801(a)(3); MISBRANDING
Charge: The article appears to be a color additive the
intended use of which is for the purpose of coloring only,
and its packaging and labeling do not conform to regulations
issued under section 721.
Reason: DRUG GMPS
Section: 501(a)(2)(B), 801(a)(3); ADULTERATION
Charge: It appears that the methods used in or the
facilities or controls used for manufacture, processing,
packing, or holding do not conform to or are not operated or
administered in conformity with current good manufacturing
Reason: DRUG NAME
Section: 502(e)(1); 801(a)(3); Misbranding
Charge: The article appears to be a drug and fails to bear
the proprietary or established name and/or name and quantity
of each active ingredient.
Reason: DULCIN
Section: 402(a)(2)(C); 801(a)(3)
Charge: The article appears to bear or contain dulcin, an
unsafe food additive within the meaning of Section 409
Reason: DV NAME
Section: 502(e)(2); 801(a)(3); Misbranding
Charge: The article appears to be a device and its labeling
fails to bear the proprietary or established name.
Reason: DV QUALITY
Section: 501(c); 801(a)(3) Adulteration
Charge: The article appears to be a device whose quality
falls below that which it purports or is represented to
possess.
Reason: EPHEDALK
Section: 801(a)3), 402(f)(1); ADULTERATION
Charge: The product is subject to refusal of admission
pursuant to Section 801(a)(3) in that it is a dietary
supplement or a dietary ingredient that appears to contain
ephedrine alkaloids, which presents an unreasonable risk of
Reason: EXCESS SUL
Section: 402(a)(1), 801(a)(3); ADULTERATION
Charge: The article appears to contain excessive sulfites, a
poisonous and deleterious substance which may render it
injurious to health.
Reason: EXPIRED
Section: 501(c); 801(a)(3) Adulteration
Charge: the product strength differs from, or its purity or
quality falls below, that which it purports or is
represented to possess in that it is past its labeled
expiration date.
Reason: FAILS STD
Section: 501(e), 801(a)(3); ADULTERATION
Charge: The article appears to be a device which is subject
to a performance standard established under Section 514 and
does not appear to be in all respects in conformity with
such standard.
Reason: FALSE
Section: 403(a)(1), 801(a)(3); MISBRANDING
Charge: the labeling appears to be false and misleading in
any particular.
Reason: FALSE
Section: 502(a), 801(a)(3); MISBRANDING
Charge: The labeling for this article appears to be false or
misleading in that it fails to reveal a material fact
Reason: FALSECAT
Section: 403(t), 801(a)(3)
Charge: The article is subject to refusal of admission
pursuant to section 801(a)(3) in that it appears to be
misbranded because it purports to be or is represented as
catfish but is not a fish classified within the family
Reason: FEED & NAD
Section: 501(a)(6), 801(a)(3); ADULTERATION
Charge: The article appears to be an animal feed bearing or
containing a new animal drug, and such animal feed is unsafe
within the meaning of section 512.
Reason: FILTH
Section: 601(b), 801(a)(3); ADULTERATION
Charge: The cosmetic appears to consist in whole or in part
of any filthy, putrid, or decomposed substance.
Reason: FILTHY
Section: 402(a)(3), 801(a)(3); ADULTERATION
Charge: The article appears to consist in whole or in part
of a filthy, putrid, or decomposed substance or be otherwise
unfit for food.
Reason: FLAVR LBLG
Section: 403(k), 801(a)(3); MISBRANDING
Charge: The article appears to contain an artificial
flavoring and it fails to bear labeling stating that fact.
Reason: FLUOROCARB
Section: 501(a)(5), 801(a)(3); ADULTERATION
Charge: The article appears to be a new animal drug
containing chloroflurocarbons in violation of 21 CFR 2.125.
Reason: FLUOROCARB
Section: 402(a)(2)(A), 801(a)(3); ADULTERATION
Charge: The article appears to contain chloroflurocarbons in
violation of 21 CFR 2.125.
Reason: FLUOROCARB
Section: 601(a), 801(a)(3); ADULTERATION
Charge: The article appears to contain chloroflurocarbons in
violation of 21 CFR Part 2.125.
Reason: FORBIDDEN
Section: 801(a)(2); FORBIDDEN OR RESTRICTED IN SALE
Charge: The article appears to be forbidden or restricted in
sale in the country in which it was produced or from which
it was exported.
Reason: FOREIGN OB
Section: 402(a)(3), 801(a)(3); ADULTERATION
Charge: The article appears to consist in whole or in part
of a filthy, putrid, or decomposed substance, or is
otherwise unfit for food in that it appears to contain
foreign objects.
Reason: FRNMFGREG
Section: 502(o), 801(a)(3); MISBRANDING
Charge: The foreign manufacturer has not registered as
required by section 510(i)(1)
Reason: GINSENG
Section: 402(a)(2)(C), 801(a)(3); ADULTERATION
Charge: The article appears to bear or contain "Ginseng", a
food additive which is unsafe within the meaning of Section
409.
Reason: HEALTH C
Section: 801(a)(3); 403(r)(1)(A)/(B) misbranding
Charge: The article appears to be misbranded in that the
label or labeling bears an unauthorized nutrient
content/health claim.
Reason: HELD INSAN
Section: 601(c), 801(a)(3); ADULTERATION
Charge: The cosmetic appears to have been prepared, packed,
or held under insanitary conditions whereby it may have
become contaminated with filth, or whereby it may have been
rendered injurious to health.
Reason: HEPATITISA
Section: Section 801(a)(3), 402(a)(1); ADULTERATION
Charge: The article appears to contain Hepatitis A Virus, a
poisonous or deleterious substance which may render it
injurious to health.
Reason: HISTAMINE
Section: 402(a)(1), 801(a)(3); Adulteration
Charge: The article appears to bear or contain histamine, a
poisonous and deleterious substance in such quantity as
ordinarily renders it injurious to health.
Reason: HOLES
Section: 501(c); 801(a)(3) Adulteration
Charge: The quality of the article falls below that which it
purports or is represented to possess, in that the devices
contain defects/holes.
Reason: IMBED OBJT
Section: 402(d)(1), 801(a)(3); ADULTERATION
Charge: The article appears to be a confectionary that has
partially or completely imbedded therein any nonnutritive
object.
Reason: IMITATION
Section: 403(c), 801(a)(3); MISBRANDING
Charge: The article appears to be an imitation of another
food, and the label does not bear in type of uniform size
and prominence, the word "imitation" and immediately
thereafter, the name of the food imitated.
Reason: IMPTRHACCP
Section: 801(a)(3) , 402(a)(4) Adulteration
Charge: The food appears to have been prepared, packed or
held under insanitary conditions, or may have become
injurious to health, due to the failure of the importer to
provide verification of compliance pursuant to 21 CFR
Reason: INCONSPICU
Section: 502(c), 801(a)(3); MISBRANDING
Charge: Information required by the Act to be on the label
or labeling does not appear to be conspicuous enough as to
render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
Reason: INCONSPICU
Section: 403(f), 801(a)(3); MISBRANDING
Charge: Information required by the Act to be on the label
or labeling does not appear to be conspicuous enough as to
render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
Reason: INGRED FIL
Section: 402(a)(4), 801(a)(3); Adulteration
Charge: The article appears to be an ingredient in a dietary
supplement and may have been prepared packed or held under
insanitary conditions whereby it may have become
contaminated with filth or rendered injurious to health.
Reason: INSAN BSE
Section: 402(a)(4), 801(a)(3); Adulteration
Charge: The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to have
been prepared, packed or held under insanitary conditions
whereby it may have been rendered injurious to health.
Reason: INSANITARY
Section: 501(a)(2)(A), 801(a)(3); ADULTERATION
Charge: The article appears to have been prepared, packed or
held under insanitary conditions whereby it may have been
contaminated with filth, or whereby it may have been
rendered injurious to health.
Reason: INSANITARY
Section: 402(a)(4), 801(a)(3); ADULTERATION
Charge: The article appears to have been prepared, packed,
or held under insanitary conditions whereby it may have
become contaminated with filth, or whereby it may have been
rendered injurious to health.
Reason: INSULIN
Section: 502(k), 801(a)(3); MISBRANDING
Charge: The drug appears to purport, or represented as,
being composed wholly or partly of insulin and it does not
appear to be from a batch with respect to which a
certificate or release has been issued pursuant to section
Reason: INVDEVICE
Section: 501(i), 801(a)(3); ADULTERATION
Charge: The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to be a
device for investigational use for which no exemption has
been granted as prescribed by Section 520(g)
Reason: JUICE %
Section: 403(i)(2), 801(a)(3); MISBRANDING
Charge: It appears the food is a beverage containing
vegetable or fruit juice and does not bear a statement on
the label in appropriate prominence on the information panel
of the total percentage of such fruit or vegetable juice
Reason: LABELING
Section: Section 4(a); 801(a)(3) Misbranding
Charge: The article appears in violation of FPLA because of
its placement, form and/or contents statement.
Reason: LACK NOTIF
Section: 301(s)
Charge: Adulterated, 801(a)(3), lack of documentation
establishing that the infant formula meets all notification
conditions required by 412(c) or 412(d), Prohibited Act,
Section 301(s).
Reason: LACKS FIRM
Section: 403(e)(1), 801(a)(3); MISBRANDING
Charge: The food is in package form and appears to not bear
a label containing the name and place of business of the
manufacturer, packer, or distributor.
Reason: LACKS FIRM
Section: 502(b)(1), 801(a)(3); MISBRANDING
Charge: The article is in package form and appears to not
bear a label containing the name and place of business of
the manufacturer, packer, or distributor.
Reason: LACKS N/C
Section: 403(e)(2), 801(a)(3); MISBRANDING
Charge: The food is in package form and appears to not have
a label containing an accurate statement of the quantity of
the contents in terms of weight, measure or numerical count
and no variations or exemptions have been prescribed by
Reason: LACKS N/C
Section: 502(b)(2), 801(a)(3); MISBRANDING
Charge: The article is in package form and appears to not
have a label containing an accurate statement of the
quantity of the contents in terms of weight, measure or
numerical count and no variations or exemptions have been
Reason: LBL STEEL
Section: 502(a); 801(a)(3); Misbranding
Charge: The labeling for this article appears to be false or
misleading: labeling suggests it is composed of stainless
steel, but it doesn't meet standard requirements for the
appropriate type of stainless steel.
Reason: LBLG ADVER
Section: 502(a), 201(n) and 801(a)(3) Misbranding
Charge: The art apprs misbranded because its lblg is misledg
namely it fails to reveal facts (non-sterility) that are
material w/respect to consequences frm the use of the art
accordg to lblg or advertisg or undercondtns of customary or
Reason: LEAK/SWELL
Section: 402(a)(3), 801(a)(3); ADULTERATION
Charge: The article appears to be held in swollen containers
or contains micro leaks.
Reason: LENS CERT
Section: 502(a), 801(a)(3); MISBRANDING
Charge: The lenses are declared by accompanying certificate
to meet the requirements for impact-resistant lenses in 21
CFR 801.410 but does not appear to be impact-resistant.
Reason: LIST INGRE
Section: 403(i)(2), 801(a)(3); MISBRANDING
Charge: It appears the food is fabricated from two or more
ingredients and the label does not list the common or usual
name of each ingredient.
Reason: LISTERIA
Section: 402(a)(1), 801(a)(3); ADULTERATION
Charge: The article appears to contain Listeria, a poisonous
and deleterious substance which may render it injurious to
health.
Reason: MELAMINE
Section: 402(a)(2)(C)(i), 801(a)(3); ADULTERATION
Charge: The article is subject to refusal of admission in
that it appears to bear or contain a food additive, namely
melamine and/or a melamine analog, that is unsafe within the
meaning of section 409.
Reason: MELAMINE
Section: 402(a)(1), 801(a)(3), Adulteration
Charge: The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to bear or
contain a food additive, namely melamine and/or a melamine
analog, that is unsafe within the meaning of Section 409
Reason: MELAMINE
Section: 402(a)(2)(C)(i), 801(a)(3); ADULTERATION
Charge: The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to bear or
contain a food additive, namely melamine and/or a melamine
analog, that is unsafe within the meaning of section 409
Reason: MFR INSAN
Section: 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING
Charge: The article appears to have been manufactured,
processed, or packed under insanitary conditions.
Reason: MFRHACCP
Section: 402(a)(4), 801(a)(3)
Charge: The product appears to have been prepared, packed,
or held under insanitary conditions, or it may be injurious
to health, due to failure of the foreign processor to comply
with 21 CFR 123.
Reason: N-RX INACT
Section: 502(e)(1); 801(a)(3); Misbranding
Charge: The article appears to be a nonprescription drug and
fails to bear the established name of each inactive
ingredient in alphabetical order on the outside container of
the retail package.
Reason: NEEDS ACID
Section: 402(a)(4), 801(a)(3); ADULTERATION
Charge: The food appears to have been prepared, packed, or
held under insanitary conditions, or it may have been
rendered injurious to health due to inadequate
acidification.
Reason: NEEDS FCE
Section: 402(a)(4), 801(a)(3); ADULTERATION
Charge: It appears the manufacturer is not registered as a
low acid canned food or acidified food manufacturer pursuant
to 21 CFR 108.25(c)(1) or 108.35(c)(1).
Reason: NEW VET DR
Section: 501(a)(5), 801(a)(3); ADULTERATION
Charge: The article appears to be a new animal drug which is
unsafe within the meaning of Section 512(a) in that there is
not in effect an approval of an applications filed with
respect to its intended use or uses.
Reason: NITROFURAN
Section: 402(a)(2)(C)(i), 801(a)(3); Adulteration
Charge: The article is subject to refusal of admission in
that it appears to bear or contain a food additive, namely
nitrofurans, that is unsafe.
Reason: NO 510(K)
Section: 801(a)(3); 502(o) Misbranding
Charge: It appears that a notice or other information
respecting the device was not provided to FDA, as required
by Section 510(k) and the device was not found to be
substantially equivalent to a predicate device.
Reason: NO ENGLISH
Section: 502(c); 801(a)(3);Misbranding
Charge: Required label or labeling appears to not be in
English in violation of 21 C.F.R. 801.15(c)(1)
Reason: NO ENGLISH
Section: 403(f), 801(a)(3); MISBRANDING
Charge: Required label or labeling appears to not be in
English per 21 CFR 101.15(c).
Reason: NO ENGLISH
Section: 502(c); 801(a)(3) ;MISBRANDING
Charge: Required label or labeling appears to not be in
English in violation of 21 C.F.R. 201.15(c)(1).
Reason: NO LICENSE
Section: 502(f)(1), 801(a)(3); MISBRANDING & PHS BIOL. ACT 351
Charge: The article appears to be a biological product not
manufactured at an establishment holding an unsuspended and
unrevoked license issued under the Public Health Service
Act, Biological Products section 351.
Reason: NO PERMIT
Section: 1, 2; PROHIBITION WITHOUT PERMIT
Charge: The article of milk or cream is not accompanied by a
valid import milk permit, as required by the Federal Import
Milk Act (21 U.S.C. 141-149).
Reason: NO PMA
Section: 501(f)(1)(B), 801(a)(3); ADULTERATION
Charge: The article appears to be a class III device without
an approved application for premarket approval pursuant to
section 515(a).
Reason: NO PMA/PDP
Section: 501(f)(1)(A); 801(a)(3); ADULTERATION
Charge: The article appears to be a class III dev.w/o an
approved applic. for premarket approval, and/or a notice of
completion of product development protocol filed per
sect.515(b) or exempt per sect.520(g)(1). [Adulteration,
Reason: NO PROCESS
Section: 402(a)(4), 801(a)(3); ADULTERATION
Charge: It appears that the manufacturer has not filed
information on its scheduled process as required by 21 CFR
108.25(c)(2) or 108.35(c)(2).
Reason: NO REGISTR
Section: 536(a); Failure to file initial report
Charge: The article appears to be an electronic product that
does not comply with an applicable standard as prescribed by
Section 534 because no reporting has been provided as
required by Section 537(b).
Reason: NO TAG
Section: 536(a),(b); NOT CERTIFIED
Charge: It appears that the article does not have affixed to
it a certification in the form of a label or tag in
conformity with section 534(h).
Reason: NOCONTCODE
Section: 402(a)(4), 801(a)(3); ADULTERATION
Charge: The low acid or acidified food appears to have been
prepared, packed, or held under insanitary conditions, or it
may be injurious to health, due to failure to mark with a
permanent container code pursuant to 21 CFR 113.60(c) or
Reason: NON STD
Section: 536(a),(b); NON STANDARD
Charge: It appears that the article fails to comply with
applicable standards prescribed under section 534.
Reason: NONNUT SUB
Section: 402(d)(3), 801(a)(3); ADULTERATION
Charge: The article appears to be confectionery and it bears
or contains a nonnutritive substance.
Reason: NONRSP-PRC
Section: 402(a)(4), 801(a)(3); ADULTERATION
Charge: The article appears to have been prepared or packed
under insanitary conditions whereby it may have been
rendered injurious to health due to inadequate processing in
that the scheduled process filed by the manufacturer
Reason: NONRSP-VER
Section: 402(a)(4), 801(a)(3); ADULTERATION
Charge: The article appears to have been prepared or packed
under insanitary conditions whereby it may have been
rendered injurious to health due to inadequate processing in
that the scheduled process filed by the manufacturer
Reason: NONSTEEL
Section: 502(a) and/or 502(f)(1); Misbranding
Charge: Labeling appears false or misleading or fails to
bear adequate directions for use,because the article appears
to be misrepresented as a disposable single use instrument
when it is intended for use as a stainless steel multi-use
Reason: NOT IMPACT
Section: 501(c), 801(a)(3); ADULTERATION
Charge: The article appears to not have impact-resistant
lenses in accordance with 21 CFR 801.410.
Reason: NOT LISTED
Section: 502(o), 801(a)(3); MISBRANDING
Charge: It appears the drug or device is not included in a
list required by Section 510(j), or a notice or other
information respecting it was not provided as required by
section 510(j) or 510(k).
Reason: NUTR DEF
Section: 412(a)(1), 801(a)(3); Adulterated
Charge: the infant formula appears to adulterated in that it
does not provide the nutrients required by 21 CFR 107.100
Reason: NUTR UNIT
Section: 403(f), 801(a)(3); MISBRANDED
Charge: The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that the infant formula
appears to be misbranded within the meaning of Section 403
in that the labeling fails to use the proper units to
Reason: NUTRIT LBL
Section: 403(q); 801(a)(3); Misbranding
Charge: The article appears to be misbranded in that the
label or labeling fails to bear the required nutrition
information.
Reason: OFF ODOR
Section: 402(a)(3), 801(a)(3); ADULTERATION
Charge: The article appears to consist in whole or in part
of a filthy, putrid, or decomposed substance or be otherwise
unfit for food. Contains an off odor.
Reason: OMITTED
Section: 402(b)(1), 801(a)(3); ADULTERATION
Charge: It appears that a valuable constituent of the
article has been in whole or in part omitted or abstraced
from the article.
Reason: OPTION ING
Section: 403(g)(2), 801(a)(3); MISBRANDING
Charge: It appears to be a food for which a definition and
standard of identity have been prescribed by regulations
under section 401 and appears to not be labelled with the
common names of the optional ingredients specified therein.
Reason: PATULIN
Section: 402(a)(1), 801(a)(3); ADULTERATION
Charge: The article appears to contain patulin, a poisonous
and deleterious substance which may render it injurious to
health.
Reason: PB-FOOD
Section: 402(a)(1); 801(a)(3); Adulteration
Charge: The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to contain
a poisonous or deleterious substance, lead, which may
render it injurious to health.
Reason: PERSONALRX
Section: 502(a) & (f)(1), 801(a)(3); MISBRANDING
Charge: The article appears to be a drug which requires a
prescription from your doctor.
Reason: PESTICIDE
Section: 402(a)(2)(B), 801(a)(3); ADULTERATION
Charge: The article appears to be a raw agricultural
commodity that bears or contains a pesticide chemical which
is unsafe within the meaning of Section 408(a).
Reason: PESTICIDES
Section: 402(a)(2)(B), 802(a)(B); ADULTERATION
Charge: The article is subject to refusal of admission
pursuant to section 801(a)(3) in that it appears to be
adulterated because it contains a pesticide chemical, which
is in violation of section 402(a)(2)(B). Contains:
Reason: POIS CHLOR
Section: 402(a)(1), 801(a)(3); ADULTERATION
Charge: The article appears to contain a poisonous or
deleterious substance, namely chloramphenicol, which may
render it injurious to health.
Reason: POISON PKG
Section: 502(p), 801(a)(3); MISBRANDING
Charge: The article appears to be a drug and its packaging
and labeling is in violation of an applicable regulation
issued pursuant to section 3 or 4 of the Poison Prevention
Packaging Act of 1970.
Reason: POISONOUS
Section: 402(a)(1), 801(a)(3); ADULTERATION
Charge: The article appears to contain a poisonous or
deleterious substance which may render it injurious to
health.
Reason: POISONOUS
Section: 601(a), 801(a)(3); ADULTERATION
Charge: The cosmetic appears to bear or contain a poisonous
or deleterious substance which may render it injurious to
users under the conditions prescribed in the labeling
thereof, or, under such conditions of use as are customary
Reason: POSS N/STR
Section: 501(a)(1); 801(a)(3) ADULTERATION
Charge: The article appears to consist in whole or in part
of any filthy, putrid, or decomposed substance, namely,
potentially infectious organisms
Reason: PRESRV LBL
Section: 403(k), 801(a)(3); MISBRANDING
Charge: The article appears to contain a chemical
preservative and it fails to bear labeling stating that fact
including its function.
Reason: RADIONUC
Section: 402(a)(1); 801(a)(3); Adulteration
Charge: Article appears to contain the radionuclide,
Cesium-137, a poisonous and deleterious substance which may
render it injurious to health.
Reason: RECORDS
Section: 502(t), 801(a)(3); MISBRANDING
Charge: The article appears to be a device and the
requirements under 518 or to furnish any material or
information required by or under section 519 respecting a
device were not met.
Reason: REDUCED
Section: 501(d)(1), 801(a)(3); ADULTERATION
Charge: It appears to be a drug that a substance has been
mixed or packed with so as to reduce its strength.
Reason: REGISTERED
Section: 502(o), 801(a)(3); MISBRANDING
Charge: It appears the device is subject to listing under
510(j) and the initial distributor has not registered as
required by 21 CFR 807.20 (a)(4).
Reason: REJECT TEA
Section: 1 (21USC41); PROHIBITED TEA
Charge: The article is inferior in purity, quality, and
fitness for consumption to the standards provided in section
43.TEA ACT REPEALED!
Reason: RX DEVICE
Section: 502(a),(f)(1), 801(a)(3); MISBRANDING
Charge: The article appears to be a prescription device
without a prescription device legend as required by 21 CFR
801.109.
Reason: RX LEGEND
Section: 502(a) & (f)(1), 801(a)(3); MISBRANDING
Charge: The article appears to be a prescription drug
without a prescription drug legend as required by Section
503(b)(4).
Reason: RXCOMPOUND
Section: 503(b)(4)(A) & 502(c), 801(a)(3); MISBRANDING
Charge: the labeling fails to bear, at a minimum, the symbol
"Rx only."
Reason: RXPERSONAL
Section: 502(a), 502(f)(1), 801(a)(3), MISBRANDING
Charge: The article appears to be a device which requires a
prescription from your doctor.
Reason: SACCHARIN
Section: 403(o); 801(a)(3) Misbranded
Charge: The article contains Saccharin, a non-nutritive
sweetner, and its label or labeling fails to bear the
required warning statement.
Reason: SACCHARLBL
Section: 403(i); 803(a)(3) Misbranding
Charge: The article contains Saccharin, a non-nutritive
sweetener, and its label or labeling fails to list it as an
added ingredient
Reason: SALMONELLA
Section: 402(a)(1), 801(a)(3); ADULTERATION
Charge: The article appears to contain Salmonella, a
poisonous and deleterious substance which may render it
injurious to health.
Reason: SBGINSENG
Section: 801(a)(3); 403(u) Misbranding
Charge: The article is subject to refusal of admission in
that it appears to be Misbranded because it or its
ingredients purport to be or are represented as Ginseng, but
are not an herb or herbal ingredient derived from a plant
Reason: SHIGELLA
Section: 402(a)(1), 801(a)(3); ADULTERATION
Charge: The article appears to contain Shigella, a poisonous
and deleterious substance which may render it injurious to
health.
Reason: SOAKED/WET
Section: 402(a)(4), 801(a)(3); ADULTERATION
Charge: The article appears to have been prepared, packed,
or held under insanitary conditions whereby it may have
become contaminated with filth, or whereby it may have been
rendered injurious to health in that it appears to been held
Reason: STAINSTEEL
Section: 501(c); 801(a)(3) Adulteration
Charge: The article appears to be a device whose quality
falls below that which it purports or is represented to
possess, in that instrument is represented as stainless
steel but does not meet requirements for such steel for
Reason: STARANISE
Section: 402(a)(2)(C)(i), 801(a)(3), Adulteration
Charge: The article appears to bear or contain a food
additive, Japanese star anise, that is unsafe within the
meaning of section 409.
Reason: STD FILL
Section: 403(h)(2), 801(a)(3); MISBRANDING
Charge: The article appears to be represented as a food for
which a standard of fill of container has been prescribed by
regulations as provided by section 401 and it appears it
falls below the standard of fill and its label does not so
Reason: STD IDENT
Section: 403(g)(1), 801(a)(3); MISBRANDING
Charge: The food appears to be represented as a food for
which a definition and standard of identity have been
prescribed by regulations as provided by section 401 and the
food does not appear to conform to such definition and
Reason: STD LABEL
Section: 502(s), 801(a)(3); MISBRANDING
Charge: The article appears to not bear labeling prescribed
by the performance standard established under section 514.
Reason: STD NAME
Section: 403(g)(2), 801(a)(3); MISBRANDING
Charge: It appears to be a food for which a definition and
standard of identity have been prescribed by regulations
under section 401 and appears to not be labelled with the
name specified in the definition and standard.
Reason: STD QUALIT
Section: 403(h)(1), 801(a)(3); MISBRANDING
Charge: The article appears to be represented as a food for
which a standard of quality has been prescribed by
regulation as provided by Sec. 401 and it appears its
quality falls below such standard and its label does not so
Reason: STERILITY
Section: 501(a)(2)(A), 801(a)(3); ADULTERATION
Charge: The article appears to have been prepared, packed or
held under insanitary conditions whereby it may have been
contaminated with filth, or whereby it may have been
rendered injurious to health.
Reason: STERILITY
Section: 501(a)(1), 801(a)(3); ADULTERATION
Charge: The article appears to consist in whole or in part
of any filthy, putrid, or decomposed substance.
Reason: SUBSTITUTE
Section: 402(b)(2), 801(a)(3); ADULTERATION
Charge: It appears that a substance has been substituted
wholly or in part for one or more of the article's
ingredients.
Reason: SUBSTITUTE
Section: 501(d)(2), 801(a)(3); ADULTERATION
Charge: It appears to be a drug that a substance has been
substituted wholly or in part.
Reason: SULFITELBL
Section: 403(a)(1), 801(a)(3) ;MISBRANDING
Charge: The article is subject to refusal of admission
pursuant to section 801(a)(3) in that it appears to be
misbranded because 1) it appears to contain sulfites but the
label fails to declare the presence of sulfites, a fact
Reason: TAMPERING
Section: 501(a)(2)(B), 801(a)(3); ADULTERATION
Charge: It appears that the packing does not conform with
current good manufacturing practices under 21 CFR 211.132
for tamper-resistant packaging.
Reason: TISSUE
Section: 361
Charge: This human cell, tissue, and cellular and
tissue-based product is in violation of Section 361 of the
Public Health Service Act.
Reason: TRANSFAT
Section: 403(q), 801(a)(3) ;MISBRANDING
Charge: The product is misbranded under Section 403(q)
because the nutrition label does not provide all of the
information required by 21 CFR 101.9(c); specifically, the
label does not bear the amount of trans fat [21 CFR
Reason: UNAPPROVED
Section: 505(a), 801(a)(3); UNAPPROVED NEW DRUG
Charge: The article appears to be a new drug without an
approved new drug application.
Reason: UNDER PRC
Section: 402(a)(4), 801(a)(3); ADULTERATION
Charge: The article appears to have inadequate processing in
having been prepared, packed, or held under insanitary
conditions whereby it may have been rendered injurious to
health.
Reason: UNFIT4FOOD
Section: 402(a)(3), 801(a)(3); ADULTERATION
Charge: The article is subject to refusal of admission
pursuant to section 801(a)(3) in that it appears to be unfit
for food [Adulteration, 402(a)(3)]
Reason: UNSAFE ADD
Section: 402(a)(2)(C)(i), 801(a)(3); ADULTERATION
Charge: The article appears to bear or contain a food
additive which is unsafe within the meaning of Section 409.
Contains
Reason: UNSAFE COL
Section: 501(a)(4)(B), 801(a)(3); ADULTERATION
Charge: The article appears to be a color additive for the
purposes of coloring only in or on drugs or devices, and is
unsafe within the meaning of Section 721(a).
Reason: UNSAFE COL
Section: 402(c), 801(a)(3); ADULTERATION
Charge: The article appears to be, or to bear or contain a
color additive which is unsafe within the meaning of Section
721(a).
Reason: UNSAFE SUB
Section: 402(a)(2)(A), 801(a)(3); ADULTERATION
Charge: The article appears to bear or contain a substance
which is unsafe within the meaning of Section 406.
Reason: UNSFDIETLB
Section: 402(f)(1)(A), 801(a)(3) Adulteration
Charge: The article appears to be a dietary supplement or
contain a dietary ingredient that presents a significant or
unreasonable risk of illness or injury under the conditions
of use set out in the labeling or, if none are set out in
Reason: UNSFDIETSP
Section: 402(f)(1)(B), 801(a)(3) Adulteration
Charge: The article appears to be a dietary supplement or
ingredient for which there is inadequate information to
provide reasonable assurance that such ingredient does not
present a significant or unreasonable risk of illness or
Reason: UNSFDIETUS
Section: 402(f)(1)(D), 801(a)(3) Adulteration
Charge: The article is or contains a dietary supplement that
renders it adulterated under paragraph (a)(1) under
conditions of use recommended or suggested in the labeling
of such dietary supplement.
Reason: USUAL NAME
Section: 403(i)(1), 801(a)(3); MISBRANDING
Charge: It appears that the label does not bear the common
or usual name of the food.
Reason: VET LEGEND
Section: 502(a) & (f)(1), 801(a)(3); MISBRANDING
Charge: The article appears to be a veterinary drug without
the "Caution" statement as required by Section 503(f)(4).
Reason: VETDRUGRES
Section: 402(a)(2)(C)(ii); 801(a)(3); ADULTERATION
Charge: The article appears to contain a new animal drug (or
conversion product thereof) that is unsafe within the
meaning of section 512. Product contains
Reason: VITAMN LBL
Section: 403(a)(2), 801(a)(3); MISBRANDING
Charge: The food appears to be subject to section 411 and
its advertising is false or misleading in a material respect
or its labeling is in violation of section 411(b)(2).
Reason: WARNINGS
Section: 502(f)(2), 801(a)(3); MISBRANDING
Charge: It appears to lack adequate warning against use in a
pathological condition or by children where it may be
dangerous to health or against an unsafe dose, method,
administering duration, application, in manner/form, to
Reason: WRONG IDEN
Section: 403(b), 801(a)(3); MISBRANDING
Charge: The article appears to be offered for sale under the
name of another food.
Reason: YELLOW #5
Section: 402(c), 403(m), 801(a)(3); ADULTERATION, MISBRANDING
Charge: The food appears to bear or contain the color
additive FD & C Yellow No. 5, which is not declared on the
label per 21 CFR 74.705 under section 721.