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: Honey, at New Munster, Wis. (E.D. Wis.); Civil Action No. 97-C-0536.
CHARGED 5-5-97: While held for sale after shipment in interstate commerce at Best Bargains, Inc., in New Munster, Wis., the article was adulterated in that another substance, cane or corn sugar syrup, had been substituted in whole or in part for honey--402(b)(2). The article was misbranded in that the name on its labeling, honey, was false and misleading as applied to an article of food which was not pure honey and which consisted largely of another substance--403(a)(1).
DISPOSITION: The article was destroyed. (F.D.C. No. 67186; S. No. 97-562-238; S.J. No. 1)

PRODUCT: Infant Formula, at Wampum, Pa. (W.D. Pa.); Civil Action No. 95 1814 and 95 1991.
CHARGED 12-8-95: While held for sale after shipment in interstate commerce at Gateway Commerce Center, in Wampum, Pa., the articles were misbranded in that their labeling was false and misleading--403(a)(1).
DISPOSITION: The articles were either destroyed or reconditioned. (F.D.C. No. 67110; S. No. 96-787-061; S.J. No. 2)

PRODUCT: Peppers, at Brooklyn, New York (E.D. N.Y.); Civil Action No. CV-96-1230.
CHARGED 3-18-96: While held for sale after shipment in interstate commerce at Adamba Imports International, in Brooklyn, N.Y., the articles were adulterated in that they had been shipped and 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. 67124; S. No. 95-752-931; S.J. No. 3)

PRODUCT: Sodium Citrate, at Springfield, Mo. (W.D. Mo.); Civil Action No. 94-3152-CV-S-4.
CHARGED 4-12-94: While held for sale after shipment in interstate commerce at G.S. Robins and Company, in Springfield, Mo., the article was adulterated in that it was unfit for food because of the presence of foreign material, including plant matter and a rubber-like material visible to the naked eye--402(a)(3).
DISPOSITION: The article was reconditioned for nonfood use. (F.D.C. No. 66954; S. No. 94-688-047; S.J. No. 4)

Drugs/Human Use

PRODUCT: An article of drug, at Eau Claire, Wis. (W.D. Wis.); Civil Action No. 96 C 1016 S.
CHARGED 12-17-96: While held for sale after shipment of one or more of their components in interstate commerce at Radix Laboratories, Inc., in Eau Claire, Wis., the article was adulterated in that it was a new animal drug within the meaning of 201(v)(1) and was unsafe within the meaning of 512(a)(1)(A) because no approval of an application filed pursuant to 512(b) was in effect with respect to its intended use.
DISPOSITION: The article was destroyed. (F.D.C. No. 67158; S. No. 96-718-764; S.J. No. 5)

Medical Devices

PRODUCT: Test Kits, at Irvine, Calif. (C.D. Calif.); Civil Action No. CV 97-0524-ABC (VAP).
CHARGED 1-27-97: While held for sale after shipment in interstate commerce at IBEX Medical Group, in Irvine, Calif., the articles were adulterated in that they were a class III device without an application for premarket approval--501(f)(1)(B). The articles were misbranded in that the label failed to contain the name and place of business of the manufacturer, packer or distributor--502(b)(1), and failed to bear the established name of the device--502(e)(2). Also, notice or other information respecting the device was not provided to the Food and Drug Administration at least 90 days prior to its introduction into interstate commerce--502(o).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67161; S. No. 97-683-594; S.J. No. 6)

PRODUCT: Test Kits, at Beverly Hills, Calif. (C.D. Calif.); Civil Action No. CV 97-1751-GHK (RCx).
CHARGED 3-18-97: While held for sale after shipment in interstate commerce at the residence of David Rudich, in Beverly Hills, Calif., the articles were adulterated in that they were a class III device without an application for premarket approval--501(f)(1)(B). The articles were misbranded in that the label failed to contain the name and place of business of the manufacturer, packer or distributor--502(b)(1), and the label failed to bear the established name of the device--502(e)(2). Also, notice or other information respecting the device was not provided to the Food and Drug Administration at least 90 days prior to its introduction into interstate commerce--502(o).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67173; S. No. 97-789-608; S.J. No. 7)

INJUNCTION ACTIONS

DEFENDANT: Central Grocers Cooperative, Inc., Robert J. Wagner, Joseph Caccamo, and individuals, at Franklin Park, Ill. (N.D. Ill.); Civil No. 97-C-2052.
CHARGED 3-25-97: While held for sale after shipment in interstate commerce at Central Grocers Cooperative, Inc., in Franklin Park, Ill., 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: A consent decree of permanent injunction was granted. Central Grocers Cooperative, Inc., was ordered to pay all civil penalties in this action. (Inj. No. 1411; S. No. 97-759-321; S.J. No. 8)

DEFENDANTS: MinXray, Inc., and Keith R. Kretchmer, at Northbrook, Ill., (N.D. Ill.); Civil Action No. 96 C 1062.
CHARGED 2-23-96: While held for sale after shipment in interstate commerce at MinXray, Inc., in Northbrook, Ill., the defendants manufactured and distributed x-ray units that did not comply with the applicable performance standards--538oo(a)(1); they also issued certificates that were false and misleading--538oo(a)(5)(B); and they failed to notify the purchasers that the units did not comply with applicable performance standards, failed to bring the units into compliance without charge, and failed to replace them or to refund the cost of the units--538oo(a)(2).
DISPOSITION: A consent order and judgment of permanent injunction was granted. And MinXray, Inc., was ordered to pay civil penalties in this action. (Inj. No. 1384; S. No. 95-741-232; S.J. No. 9)

FDA Consumer magazine (January-February 1998)