IA #69-01, 07/27/06 - IMPORT ALERT #69-01, "DETENTION WITHOUT PHYSICAL EXAMINATION OF
MEDICATED FEEDS CONTAINING MONENSIN FOR FAILING TO MEET ASSAY SPECIFICATIONS"
ATTACHMENT REVISED 12/24/08
TYPE OF ALERT: Detention Without Physical Examination (DWPE)
(Note: This import alert represents the Agency's current guidance
to FDA field personnel regarding the manufacturer(s) and/or
product(s) at issue. It does not create or confer any rights for
or on any person, and does not operate to bind FDA or the public).
PRODUCT: Medicated Feeds
PRODUCT
CODE: Medicated Feeds - 69A[][][][] (category I drugs)
69B[][][][] (category II drugs)
69C[][][][] (combination of category I and II
drugs)
PROBLEM: Unsafe medicated animal feed
Failure to meet label declaration of product's active ingredient
PAF: AAP (Approvals) DRA-drug ingredient analysis
LBL (Labeling)
PAC FOR
COLLECTION: 71004
COUNTRY: See Attachment
MANUFACTURER/
SHIPPER FEI#: See Attachment
CHARGES: "The article is subject to refusal of admission pursuant to Section
801(a)(3) in that it appears that it is an animal feed bearing or
containing a new animal drug, and such animal feed is unsafe within
the meaning of Section 512 [Adulteration, Section 501(a)(6)] (OASIS
CHARGE CODE: FEED & NAD)
AND
"The article is subject to refusal of admission pursuant to Section
801(a)(3) in that it appears the labeling is false and misleading
[Misbranding, Section 403(a)(1)] (OASIS CHARGE CODE: FALSE)
RECOMMENDING
OFFICE: Center for Veterinary Medicine, HFV-230
REASON FOR
ALERT: In April 2005, Buffalo District Office detained an entry of a Type
C medicated feed for cattle containing monensin analyzed as
containing 216% of declared concentration and an entry of a Type B
medicated feed containing monensin at 72.1% of declared
concentration. Both entries were from Canada. Buffalo District
Office has detained at least three other feed entries declaring
monensin because FDA testing revealed that they did not meet the
levels guaranteed by the label. Monensin is indicated for the
prevention of coccidosis in poultry, for increased feed efficiency
in cattle, and for the reduction of incidence of liver abscesses in
swine caused by a number of bacteria. Monensin is a new animal
drug, and feed containing this new animal drug must meet the
requirements of the approval, including the levels of drug present
in the feed. Feeds containing monensin and falling outside label
guarantees can pose a threat to the health of animals consuming
them.
GUIDANCE: Districts may detain without physical examination medicated feeds
from the firms listed in the attachment to this Import Alert.
Collection and examination of medicated feeds from other feed
manufacturers from Canada, or other countries appears to be
warranted. Any violative finding from Canadian feed manufacturers,
whether it is monensin or other active ingredient, should be
reported to the Canadian Food Inspection Agency (CFIA). Please
contact Jack Geltman, CVM, HFV-232, at 240-276-9203 if you have
questions regarding contacts within CFIA.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology,
contact the Division of Field Science at (301) 827-7605.
To enable the agency to assess whether the firm has identified the
source of the problem, and has taken the appropriate steps to
correct and prevent future occurrences, FDA recommends that a firm
requesting removal from detention without physical examination
provide the following information:
a. Results of the firm's investigation(s) into the
problem of monensin not meeting the label declaration.
b. Documentation showing corrective action(s) taken in
response to this investigation. This should include at
a minimum:
1) a description of the current process used to
ensure appropriate monensin levels; and
contamination; and
2) verification that the process is adequate; and
3) analytical results and supporting records,
charts, and/or chromatograms for three (3)
production batches along with their labeling
d. Documentation that a minimum of five (5) consecutive
import entries have been released by FDA based on
private laboratory analyses that show the shipments
contain monensin meeting the label declaration.
Requests to remove from the DWPE list multiple products
from a manufacturer should include a minimum of twelve
(12) import entries representative of products covered
by detention without physical examination.
All requests for removal from DWPE should be forwarded to DIOP
(HFC-170) which in turn will forward the requests to CVM for
evaluation.
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required
KEYWORDS: monensin, medicated, feeds, Type B, Type C
PREPARED BY: Jack Geltman, CVM, HFV-232, 240-276-9203
Linda Wisniowski, DIOP, HFC-172, 301-443-6553
DATE LOADED
INTO FIARS: November 10, 2005
Attachment for Import Alert #69-01 - Date 12/24/08
FIRM NAME/ADDRESS PRODUCT/CODE: REASON:
Macewan Agricentre Inc. Dairy 22% Medicated Feed Monensin
18 Lamouraux St. for Cattle (Type C Feed)
St. Isidore, Ontario 69AB[]34
Canada, K0C 2B0
FEI# 3004459408
Faubert Feeds 1979 Inc Type B Medicated Feed Monensin
5362 Route 138 69AA[]34
Huntington, Quebec
Canada J0S1H0
FEI# 1000195688
Ritchie Feed and Seed, Inc. Type B Medicated Feed Monensin
1390 Windmill Lane 69AA[]34
Ottawa, Ontario
Canada K1B 4V5
FEI# 3000101193
Great Lakes Nutrition, Inc. Heifer Pre-mix Monensin
132 Madison Street, West 69AA[]34
Moncton, Ontario
Canada
FEI# 3004292782
Meunerie Hebert Inc. 19% Dairy Feed Monensin
152 St-Georges Street (Category I, Type C 69AB-34
Henryville Medicated Feed)
Quebec, Canada J0J 1E0
FEI# 1000211592
Manufacturer
Meunerie Benjamin Inc. 16% Super Heifer Monensin
226 Haut Riviere Nord Rumensin Pellet
Saint-Cesaire, Quebec 69A[][]34
Canada J0L 1T0 12/24/2008
FEI# 3004351616
Shipper
Meunerie Robitaille Inc.
190, Comeau Nord,
Farmham, Quebec
Canada J2N 2N4
FEI# 3000036051
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