Summaries of Court Actions

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.

SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Calamari Steaks, at Nogales, Ariz. (D. Ariz.); Civil Action No. CIV-97-462-TUC ACM.
CHARGED 7-25-97: While held for sale after shipment in interstate commerce at Nogales Cold Storage, in Nogales, Ariz., the articles were adulterated in that they consisted in part of a decomposed substance by reason of the presence therein of decomposed calamari--402(a)(3). The articles were misbranded in that the label failed to bear nutrition information as required by 403(q)(5) and therefore were in violation of 403(q)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67196; S. No. 97-640-386; S.J. No. 1)

PRODUCT: Infant Formula, at Maple Heights, Ohio. (N.D. Ohio.); Civil Action No. 1:96CV2567.
CHARGED 11-27-96: While held for sale after shipment in interstate commerce at First National Supermarkets, Inc., in Maple Heights, Ohio, the articles were adulterated in that a valuable constituent, namely inositol, had been in whole or in part omitted or abstracted--402(b)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67160; S. No. 96-765-368; S.J. No. 2)

PRODUCT: Mud Skipper and Mushrooms, at Brooklyn, N.Y. (E.D. N.Y.); Civil Action No. CV 94 5466.
CHARGED 12-2-94: While held for sale after shipment in interstate commerce at Tia Wing Hong Importer Inc., in Brooklyn, N.Y., the articles were adulterated in that the mushrooms contained an added poisonous and deleterious substance, staphylococcal enterotoxin, which might render them injurious to health--402(a)(1); and, the mushrooms and mud skipper had been prepared and packed under insanitary conditions whereby they might have been rendered injurious to health--402(a)(4). In addition, the mushrooms were misbranded in that the labeling was false and misleading because it represented and suggested that the article was grown and packed in Taiwan, and that the article was sliced mushrooms, which was contrary to fact--403(a)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67019; S. No. 94-725-853; S.J. No. 3)

PRODUCT: Shrimp and Frog Legs, at Secaucus, N.J. (D.N.J.); Civil Action No. 93-CV-88.
CHARGED 1-13-93: While held for sale after shipment in interstate commerce at Flag Imports, Inc., in Secaucus, N.J., the articles were adulterated in that they contained an added poisonous and deleterious substance, Salmonella, which might render them injurious to health--402(a)(1). The articles were misbranded in that the labeling was false and misleading because it represented and suggested that the container loads contained only frozen shrimp when in fact they contained frog legs and shrimp--403(a)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66642; S. No. 92-643-263; S.J. No. 4)

Drugs/Human Use

PRODUCT: Article of Drug, at Houston, Texas (S.D. Texas); Civil Action No. H 94 2116.
CHARGED 6-21-94: While held for sale after shipment in interstate commerce at Professional Compounding Centers of America, Inc., in Houston, Texas, the defendant articles of drug were misbranded in that their labeling failed to bear adequate directions for use--352(f)(1).
DISPOSITION: The articles of drug were destroyed. (F.D.C. No. 66451; S. No. 92-451-959; S.J. No. 5)

PRODUCT: Oxygen, at Timonium, Md. (D. Md.); Civil Action No. 97-1415.
CHARGED 4-28-97: While held for sale after shipment in interstate commerce at Chesapeake Respiratory & Medical Supplies, in Timonium, Md., the defendant articles of drug were adulterated in that the methods used in, and the facilities and controls used for, their manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with current good manufacturing practice requirements of the Act--501(a)(2)(B). The articles were misbranded in that their labeling failed to bear the statement "For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Caution: Federal law prohibits dispensing without prescription."--503(b)(4).
DISPOSITION: The articles of drug were destroyed. (F.D.C. No. 67172; S. No. 96-722-724; S.J. No. 6) PRODUCT: Oxygen, at West Palm Beach, Fla. (S.D. Fla.); Civil Action No. 97-08046.
CHARGED 1-22-97: While held for sale after shipment in interstate commerce at Medical Homecare Supply, Inc., in West Palm Beach, Fla., the defendant articles of drug were adulterated in that the methods used in, and the facilities and controls used for, their manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with current good manufacturing practice requirements of the Act--501(a)(2)(B).
DISPOSITION: The articles of drug were destroyed. (F.D.C. No. 67159; S. No. 96-683-034; S.J. No. 7)

FDA Consumer magazine (September-October 1998)

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