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: Beans with ginger, preserved, at San Francisco, Calif. (N.D. Calif.); Civil No. C-94-1986-CW.
CHARGED 6-6-94: While held for sale after shipment in interstate commerce at Wing Sing Chong Co., in San Francisco, Calif., the articles were adulterated in that they contained rodent and other animal hairs, insects, and insect and feather fragments--402(a)(3).
DISPOSITION: A default decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 66981; S. No. 94-665-453; S.J. No. 1)

PRODUCT: China pud tail-off shrimp, frozen, at Tampa, Fla. (M.D. Fla.); Civil No. 95-570-Civ-T-24A.
CHARGED 4-13-95: While held for sale after shipment in interstate commerce at Ocean Duke Corp., in Tampa, Fla., the articles were adulterated in that they contained paint chips and metal fragments--402(a)(3).
DISPOSITION: The articles were exported to the foreign supplier in Hong Kong. (F.D.C. No. 67083; S. No. 95-681-861; S.J. No. 2)

PRODUCT: Fish, frozen, at Newark, N.J. (D.N.J.); Civil No. 94-9209(AJL).
CHARGED 12-21-94: While held for sale after shipment in interstate commerce at Newark Refrigerated Warehouse in Newark, N.J., the articles were adulterated in that they contained Salmonella, a poisonous or deleterious substance which might render them injurious to health--402(a)(1).
DISPOSITION: A consent decree of condemnation ordered the articles destroyed. (F.D.C. No. 67046; S. No. 94-644-161; S.J. No. 3)

PRODUCT: Fish Maws and Shark Fins, dried, at San Francisco, Calif. (N.D. Calif.); Civil No. C-94-1366-SC.
CHARGED 4-21-94: While held for sale after shipment in interstate commerce at Wonkow Enterprises, Inc., in San Francisco, Calif., the articles were adulterated in that they contained insects, rodent excreta, and animal hairs--402(a)(3). The articles were also held under insanitary conditions whereby they might have become contaminated with filth--402(a)(4).
DISPOSITION: A consent decree of condemnation ordered the articles destroyed. (F.D.C. No. 66959; S. No. 94-705-321; S.J. No. 4)

PRODUCT: Mushrooms, at Long Beach, Calif. (C.D. Calif.); Civil No. CV-94-5503-SVW(SHX).
CHARGED 8-11-94: While held for sale after shipment into interstate commerce at Great Central in Long Beach, Calif., the articles were adulterated in that they contained staphylococcal enterotoxin, a poisonous or deleterious substance which might render them injurious to health--402(a)(1). The articles were also adulterated in that they were prepared and packed under insanitary conditions whereby they might have been rendered injurious to health--402(a)(4).
DISPOSITION: A default decree ordered the articles destroyed. (F.D.C. No. 67007; S. No. 3016294; S.J. No. 5)

PRODUCT: Royal dinnerware harvest festival, at Eau Claire, Wis. (W.D. Wis.); Civil No. 95C-0357-C.
CHARGED 5-18-95: While held for sale after shipment into interstate commerce at Mid-America Tablewares, Inc., in Eau Claire, Wis., the articles were adulterated in that they contained lead--402(a)(2)(C).
DISPOSITION: A consent decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 67086; S. No. 94-718-522; S.J. No. 6)

PRODUCT: Shrimp, frozen, at Dover, Fla. (M.D. Fla.); Civil No. 95-1412-CIV-T-17A.
CHARGED 8-25-95: While held for sale after shipment in interstate commerce at Mercury Cold Storage, Inc., in Dover, Fla., the articles were adulterated in that they contained Salmonella, a poisonous or deleterious substance which might render them injurious to health--402(a)(1). The articles were also adulterated in that they consisted of decomposed shrimp --402(a)(3).
DISPOSITION: A default decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 67103; S. No. 95-711-532; S.J. No. 7)

Medical Devices

PRODUCT: Condoms, lubricated, at Paramount, Calif. (C.D. Calif.); Civil No. 95-3074.
CHARGED 5-8-95: While held for sale after shipment in interstate commerce at Handy Care in Paramount, Calif., the articles were adulterated in that their strength differed from, or their purity or quality fell below that which they represented to possess--501(c). The articles were class III devices without an application for premarket approval, and their packaging failed to bear a label containing the name and place of business of the manufacturer, packer or distributor--501(f)(1)(B) and 502(b)(1). The articles were also adulterated in that they were not manufactured in a duly registered establishment--502(o).
DISPOSITION: A default decree ordered the articles destroyed. (F.D.C. No. 67077; S. No. 95-615-695; S.J. No. 8)

INJUNCTION ACTIONS

DEFENDANTS: James' Seafood, Inc., and Elmer J. Perkins, at Lockport, La. (E.D. La.); Civil No. 94-0784.
CHARGED 3-8-94: The defendants introduced or caused to be introduced into interstate commerce adulterated crab meat--301(a). The crab meat was adulterated in that it contained Listeria monocytogenes, a poisonous or deleterious substance which might render it injurious to health, and Escherichia coli, a filthy substance--402(a)(1) and 402(a)(3). The crab meat was also adulterated in that it was prepared, packed or held under insanitary conditions whereby it might have become contaminated with filth, or whereby it might have been rendered injurious to health--402(a)(4).
DISPOSITION: The court granted an order of permanent injunction. Subsequently, the defendants went out of business. (Inj. 1334 and 1334A; S. No. 93-690-318; S.J. No. 9)

DEFENDANTS: Warner-Lambert Company, Melvin Goodes, and Lodewijk J.R. DeVink, at Morris Plains, N.J. (D.N.J); Civil No. 93-3525.
CHARGED 8-17-93: The defendants introduced or caused the introduction or delivery into interstate commerce of adulterated drugs--301(a). The drugs were adulterated in that the methods used in, and the facilities or controls used for, their manufacture, processing, packing, and holding did not conform to and were not operated or administered in conformity with current good manufacturing practice requirements--501(a)(2)(B). The defendants also manufactured, processed, packed, and labeled adulterated drugs--301(k). The defendants delivered for introduction and caused the delivery for introduction into interstate commerce new drugs without approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), or approved NDA or ANDA supplements--301(d).
DISPOSITION: A consent decree of permanent injunction was filed. Six of Warner-Lambert's manufacturing facilities were shut down except for the manufacture of certain drug products which were permitted to be manufactured under the decree. Subsequently, all facilities met the terms of the decree and were fully reopened. (Inj. No. 1322; S. No. 92-637-081; S.J. No. 10)

FDA Consumer magazine (September 1996)