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: Bean Sprouts, at Bridgeview, Ill. (N.D. Ill.); Civil Action No. 96 C 0708.
CHARGED 9-19-94: While held for sale after shipment in interstate commerce at Chicagoland Quad Cities Express in Bridgeview, Ill., the articles were adulterated in that they were held under insanitary conditions whereby they might have been rendered injurious to health--402(a)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67125; S. No. 95-760-912; S.J. No. 1)

PRODUCT: Bean Sprouts, at Chicago, Ill. (N.D. Ill.); Civil Action No. 96 C 0415.
CHARGED 1-22-96: While held for sale after shipment in interstate commerce at Worldwide Trading Company, in Chicago, Ill., the articles were adulterated in that they were held under insanitary conditions whereby they might have been rendered injurious to health--402(a)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67070; S. No. 95-710-583; S.J. No. 2)

PRODUCT: Cocoa Beans, at Brooklyn, New York (E.D. N.Y.); Civil Action No. CV-96-3907.
CHARGED 8-7-96: While held for sale after shipment in interstate commerce at Brooklyn Marine Terminal, in Brooklyn, N.Y., the articles were adulterated in that they had been shipped and held under insanitary conditions whereby they might have been contaminated with filth--402(a)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67148; S. No. 1-97-8809; S.J. No. 3)

PRODUCT: Crab Meat, frozen, at Jacksonville, Fla. (M.D. Fla.); Civil Action No. 94-662-Civ.-J-20.
CHARGED 7-11-94: While held for sale after shipment in interstate commerce at South Atlantic Cold Storage, in Jacksonville, Fla., the article was adulterated in that it consisted in part of a decomposed substance by reason of the presence therein of decomposed crab meat--402(a)(3).
DISPOSITION: The article was exported to the original foreign shipper. (F.D.C. No. 66996; S. No. 94-557-175; S.J. No. 4)

PRODUCT: Farm Cream, at Chicago, Ill. (N.D. Ill.); Civil Action No. 1-94CV5695.
CHARGED 9-19-94: While held for sale after shipment in interstate commerce at Danish Maid Butter Company, in Chicago, Ill., the articles were adulterated in that a valuable constituent, milk fat, had been, in whole or in part, omitted or abstracted therefrom--402(b)(1); and in that a substance, soybean oil, had been substituted wholly or in part for milk fat. Also, while held for sale in interstate commerce, the articles were misbranded, in that their labeling was false and misleading since it represented and suggested that the foods contained only "cream" or "milk fat," whereas they contained, in whole or in part, soybean oil--403(a)(1).
DISPOSITION: The articles were reconditioned with corrective labeling. (F.D.C. No. 67015; S. No. 94-710-925; S.J. No. 5)

PRODUCT: Mixed Vegetables, at Norfolk, Va. (E.D. Va.); Civil Action No. 2:96CV219.
CHARGED 2-27-96: While held for sale after shipment in interstate commerce at Richter Distribution Company, in Norfolk, Va., the articles were adulterated in that they were held under insanitary conditions whereby they might have been injurious to health--402(a)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67126; S. No. 96-703-775; S.J. No. 6)

Drugs/Human Use

PRODUCT: Various articles of drugs, at Rio Piedras, Puerto Rico (D.P.R.); Civil Action No. CV 96-2421(CC).
CHARGED 11-20-96: While held for sale after shipment of one or more of their components in interstate commerce at Creative Medical Corp., and at C.O.D. Drugs, Inc., in Rio Piedras, Puerto Rico, the articles 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 were destroyed. (F.D.C. No. 67155; S. No. 96-746-415; S.J. No. 7)

PRODUCT: Various articles of drugs, at St. Louis, Mo. (E.D. Mo.); Civil Action No. 4:-93CV00918.
CHARGED 4-9-96: While held for sale after shipment in interstate commerce at Highland Packaging Company, St. Louis, Mo., the articles 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: All articles were either destroyed or reconditioned. (F.D.C. No. 66706; S. No. 93-606-588; S.J. No. 8)

Medical Devices

PRODUCT: Kits, saliva and urine, at Lenexa, Kan. (D. Kan.); Civil Action No. 91-2412.
CHARGED 10-29-91: While held for sale after shipment in interstate commerce at Clinical Reference Laboratory, Inc., in Lenexa, Kan., the articles were adulterated in that they were a class III device without an application for premarket approval--501(f)(1)(B).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66261; S. No. 95-739-449; S.J. No. 9)

INJUNCTION ACTIONS

DEFENDANT: Finest Foods, Inc., d/b/a Mrs. Drakes Sandwiches, and James W. Ganus Jr., and Timothy B. Ganus, at New Orleans, La. (E.D. La.); Civil No. 93-0746.
CHARGED 1-22-93: While held for sale after shipment in interstate commerce at Finest Foods, Inc., in New Orleans, La., the articles were adulterated in that they contained Listeria monocytogenes--402(a)(1); and had been shipped and held under insanitary conditions whereby they might have been contaminated with filth--402(a)(4).
DISPOSITION: A consent decree of permanent injunction was filed. Finest Foods, Inc., was ordered to pay a fine. However, the motion as to James W. Ganus Jr. and Timothy B. Ganus was dismissed. (Inj. No. 1317; S. No. 93-689-981; S.J. No. 10)

DEFENDANTS: Inhalation Plastics, Inc., d/b/a IPI Medical Products, Walter Levin and James D. Lekkas, at Chicago, Ill., (N.D. Ill.); Civil Action No. 95 C 1965.
CHARGED 1-2-95: While held for sale after shipment in interstate commerce at Inhalation Plastics, Inc., in Chicago, Ill., the articles of devices were adulterated in that the methods used in, and the facilities and controls used for, their manufacture, preproduction design validation, packing, and storage did not conform to good manufacturing practice requirements--501(h). The articles of devices were also misbranded in that the defendants failed to file MDR reports as required--519i(a). While held for sale after shipment in interstate commerce, the articles of drugs were adulterated as well, in that the methods used in, and the facilities and controls used for, their manufacture, packing and holding did not conform to and are not operated and administered in conformity with current good manufacturing practice requirements for drugs--501(a)(2)(B).
DISPOSITION: A consent decree was filed with two separate modifications filed thereafter. (Inj. No. 1371; S. No. 94-661-701; S.J. No. 11)

FDA Consumer magazine (November-December 1997)