Summaries of Court Actions are given pursuant to Section 705 of the Federal Food, Drug, and Cosmetic Act. Summaries of Court Actions report cases involving seizure proceedings, criminal proceedings, and injunction proceedings. Seizure proceedings are civil actions taken against goods alleged to be in violation, and criminal and injunction proceedings are against firms or individuals charged to be responsible for violations. The cases generally involve foods, drugs, devices, or cosmetics alleged to be adulterated or misbranded or otherwise violative of the law when introduced into and while in interstate commerce.

Summaries of Court Actions are prepared by Food and Drug Division, Office of the General Counsel, HHS, and are published by direction of the Secretary of Health and Human Services.

PRODUCT: Claw Crabmeat, at Crawfordsville, Fla. (N.D.Fla.); Civil No. 94-40130/WS.
CHARGED 4-7-94: While held for sale after shipment in interstate commerce at Barwick Crab Company, in Crawfordsville, Fla., the article was adulterated in that it contained Listeria monocytogenes--402(a)(1). The article consisted in part of animal hair, and it contained the bacteria Escherichia coli--402(a)(3) and 402(a)(4). The article also consisted of decomposed crab meat, and it was prepared, packed and held under insanitary conditions--402(a)(3) and 402(a)(4).
DISPOSITION: Default--article was buried at a landfill. (F.D.C. No. 66931; S. No. 94-682-795; S.J. No. 1)

PRODUCT: Haddock Fillets, frozen, at Colonie, N.Y. (N.D.N.Y.); Civil No. 1:93-CV-1184 TJM/RWS.
CHARGED 9-13-93: While held for sale after shipment in interstate commerce at Golub Corporation Frozen Food Warehouse in Colonie, N.Y., the articles were adulterated in that pollock in part was substituted for haddock--402(b)(2). The articles' labeling was misleading in that it suggested that the only fish in the article was haddock--403(a)(1); and the articles offered the pollock for sale under the name of haddock--403(b).
DISPOSITION: A consent decree of condemnation and constructive destruction ordered the articles delivered to a charitable institution. (F.D.C. No. 66781; S. No. 93-579-297; S.J. No. 2)

PRODUCT: Stellated Sturgeon in tomato sauce, carp in tomato sauce, and other low-acid canned foods, at Brooklyn, N.Y. (E.D.N.Y.); Civil No. CV-94-3488.
CHARGED 7-22-94: While held for sale after shipment in interstate commerce at Western Star Foods Distributors, Inc., in Brooklyn, N.Y., the articles were adulterated in that they were prepared and packed under conditions whereby they might have been rendered injurious to health--402(a)(4); and the articles were misbranded in that the stellated sturgeon was in package form and failed to bear a label containing the name and place of business of the manufacturer, packer or distributor--403(e)(1). The label of the carp stated the name and place of business of the manufacturer, packer or distributor in a foreign language--403(f); and the articles were fabricated from two or more ingredients and their labels failed to bear the common or usual name of each such ingredient--403(i)(2).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66986; S. No. 94-691-601; S.J. No. 3)

PRODUCT: Tuna Loins, Yellow Fin, at Pensacola, Fla. (N.D.Fla.); Civil No. 94-30091/LAC.
CHARGED 3-28-94: While held for sale after shipment in interstate commerce at ATL Cold Storage Company in Pensacola, Fla., the articles were adulterated in that they contained decomposed seafood--402(a)(3).
DISPOSITION: An order of forfeiture ordered the articles destroyed. (F.D.C. No. 66942; S. No. 94-447-479; S.J. No. 4)

PRODUCT: Tuna Loins, Yellow Fin, at Seattle, Wash. (W.D.Wash.); Civil No. C94-316.
CHARGED 3-3-94: While held for sale after shipment in interstate commerce at City Ice and Cold Storage Company in Seattle, Wash., the articles were adulterated in that they contained a poisonous substance, histamine--402(a)(1); and the articles consisted in part of decomposed fish--402(a)(3).
DISPOSITION: A consent decree of condemnation, forfeiture and destruction ordered the articles destroyed. The articles were buried by the U.S. marshal at a landfill. (F.D.C. No. 66936; S. No. 94-630-112; S.J. No. 5)

Drugs/Human Use

PRODUCT: Hydrocortisone, maximum strength, at East Rutherford, N.J. (D.N.J.); Civil No. 93-3340(HLS).
CHARGED 7-28-95: While held at Ambix Laboratories in East Rutherford, N.J., the article was adulterated in that the methods used in, and the facilities and controls used for its manufacture, processing and holding did not conform to current good manufacturing practice requirements--501(a)(2)(B).
DISPOSITION: A consent decree of permanent injunction ordered the destruction of the article. (F.D.C. No. 66733; S. No. 93-707-651; S.J. No. 6)

PRODUCT: Oxygen USP, at Lake Worth, Fla. (S.D.Fla.); Civil No. 94-08695-CIV-Moreno.
CHARGED 12-1-94: While held for sale after shipment of one or more of its components in interstate commerce at Coastal Surgical in Lake Worth, Fla., the article was adulterated in that the methods used in, and the facilities and controls used for, its manufacture, processing, packaging, and holding did not conform to current good manufacturing practice requirements--501(a)(2)(B); and the adulterated article was introduced into interstate commerce--301(a).
DISPOSITION: The oxygen vessel was emptied and returned to the owner. (F.D.C. No. 67028; S. No. 94-682-963; S.J. No. 7)

PRODUCT: Oxygen USP, at Pittsburgh, Pa. (W.D.Pa.); Civil No. 93-0951.
CHARGED 6-15-93: While held for sale after shipment of one or more of its components in interstate commerce at United Health Care Services, Inc. in Pittsburgh, Pa., the article was adulterated in that the methods used in, and the facilities and controls used for, its manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with current good manufacturing practice requirements--501(a)(2)(B). The article was misbranded in that the individual home units failed to bear labeling containing a statement of the net quantity of contents--502(b)(2); and the oxygen was manufactured, prepared and processed in an unregistered establishment--502(o).
DISPOSITION: A consent decree of permanent injunction was filed, and costs were paid by the claimant. (F.D.C. No. 66715; S. No. 93-607-687; S.J. No. 8)

PRODUCT: Oxygen USP, at Rice Lake, Wis. (W.D.Wis.); Civil No. 94-C-666-S.
CHARGED 9-7-94: While held for sale at Home Medical Products and Services in Rice Lake, Wis., the article was adulterated in that the methods used in, and the facilities and controls used for its manufacture and processing did not conform to and were not operated and administered in conformity with current good manufacturing practice requirements--501(a)(2)(B).
DISPOSITION: The article was reconditioned by the firm. (F.D.C. No. 67006; S. No. 94-719-025; S.J. No. 9)

PRODUCT: Simethicone Tablets, at St. Louis, Mo. (E.D.Mo.); Civil No. 4:94CV2126 CEJ.
CHARGED 10-31-94: While held for sale after shipment in interstate commerce at GATX Logistics, Inc., in St. Louis, Mo., the articles were adulterated in that the methods used in, and the facilities and controls used for its manufacture, processing, packing, and holding did not conform with current good manufacturing practice requirements--501(a)(2)(B).
DISPOSITION: A default decree of condemnation ordered the articles destroyed. (F.D.C. No. 66987; S. No. 94-673-935; S.J. No. 10)

Drugs/Veterinary

PRODUCT: Cyan-5 Way Wormer, at Raleigh, N.C. (E.D.N.C.); Civil Action No. 5:94-CV-46-F3.
CHARGED 1-28-94: While held for sale after shipment of one or more of its components in interstate commerce at National Hog Medicine Company in Raleigh, N.C., the article was adulterated in that it was an unapproved "new animal drug"--501(a)(5), 201(w)(1), 512(b). The article was misbranded in that the labeling did not accurately state the quantity of its contents, and the labeling failed to bear the caution statement for veterinary prescription drugs--502(b)(2) and 502(c). The article was offered for sale to lay persons without the benefit of a vet/client/patient relationship, and its labeling did not bear adequate directions for its intended use--502(f)(1).
DISPOSITION: Default--article destroyed. (F.D.C. No. 66800; S. No. 93-505-983; S.J. No. 11)

Medical Devices

PRODUCT: Lymphtech Neon-Argon Photon Particle Beam Generator, at Toledo, Ohio (N.D.Ohio); Civil No. 3:93CV7466.
CHARGED 8-23-93: While held at Lymphtech N.A. in Toledo, Ohio, the article was adulterated in that it was a Class III device that did not have an application for premarket approval--501(f)(1)(B). The article was misbranded in that the labeling failed to bear adequate directions for use, and it was not manufactured in a registered establishment--502(f)(1) and 502(o).
DISPOSITION: A consent decree of condemnation was filed, and the generator was destroyed. (F.D.C. No. 66707; S. No. 93-670-824; S.J. No. 12)

DEFENDANT: James Michael Anthony, M.D., at Memphis, Tenn. (M.D.Tenn.); Criminal No. 93-20029-H.
CHARGED 2-16-93: Count 1: The defendant unlawfully exchanged the drug sample Ansaid with the drug Rocephin, which was not intended for sale, for the purpose of using Ansaid to promote the sale of Rocephin--503(c)(1) and 301(t).
Counts 2-3: The defendant intentionally obtained possession of the controlled substance Histussin by fraud--403(a)(3) of the Controlled Substances Act.
DISPOSITION: Guilty plea; ordered to pay a $150 special assessment. (F.D.C. No. 66585; S.J. No. 13)

DEFENDANTS: Highland Laboratory and Kenneth Scott, at Mt. Angel, Ore. (D.Or.); Criminal No. 93-10-IFR.
CHARGED 1-19-93: Counts 1-2: The defendant, Kenneth Scott, refused to permit an inspection by FDA of finished and unfinished materials, containers, and labeling of the drug Co-Q10 at a facility where the drug was produced, packed, and held for shipment in interstate commerce--301(f) and 303(a)(2).
Counts 3-4: The corporate defendant, Highland Laboratory, distributed unapproved new drugs with false statements regarding their usage--301(d) and 303(a)(1).
DISPOSITION: Guilty pleas. Defendant Scott was ordered to pay a $5,000 fine and a special assessment of $50 for both counts; he was sentenced to five years' probation and six months of home confinement. Highland Laboratory was sentenced to three years' probation and ordered to comply with a consent decree of permanent injunction. (F.D.C. No. Nos. 66571 and IG-18; S. No. 9-89-07301-3; S.J. No. 14)

DEFENDANTS: Craven Crab Company, Inc., Gaston B. Fulcher Jr., and J. Brent Fulcher, at New Bern, N.C. (E.D.N.C.); Civil No. 4-94-CV-9H2.
CHARGED 1-13-94: The defendants introduced adulterated crab meat into interstate commerce--301(a). The crab meat was adulterated in that it contained Listeria monocytogenes, and the crab meat was prepared, packed or held in insanitary conditions whereby it might have become contaminated with filth rendering it injurious to health--402(a)(1) and 402(a)(4).
DISPOSITION: A consent decree of permanent injunction was filed. Later, the defendants were found guilty of criminal contempt after violating the consent decree. Defendants Gaston B. Fulcher Jr. and J. Brent Fulcher were ordered to pay a $5,000 fine and to pay FDA $6,491 for inspection costs. J. Brent Fulcher was also sentenced to six months' probation, during which he must spend two weekends confined in a county correction facility. The Craven Crab Company, Inc., was ordered to pay a $10,000 fine. (Inj. No. 1337; S. No. 93-696-494; S.J. No. 16)

FDA Consumer magazine (September 1995)