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 the Office of the Chief Counsel, Food and Drug Administration.

SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Scallops, 268 cases, more or less, at Bena, Va. (E.D. Va.); Civil Action No. 4: 94CV131.
CHARGED 9-6-94: While held for sale after shipment in interstate commerce at International Seafood Distributors, Inc., at Bena, Va., the articles of food were adulterated in that a substance, water, had been added so as to increase the bulk or weight--402(b)(4).
DISPOSITION: International Seafood's facility was totally destroyed by fire, and included among the rubble were the scallops which were the subject of a consent decree of condemnation that had been entered on Dec. 1, 1994. The articles were ultimately destroyed in the proper manner, and the bond that had been posted was canceled and discharged. (F.D.C. No. 66991; S. No. 94-703-503; S.J. No. 1)

Medical Devices

PRODUCT: Elim-A-Needle, The Needle Incinerator, and accessories, at Olathe, Kan. (D. Kan.); Civil Action No. 98-1449-JTM.
CHARGED 11-30-98: While held for sale, after shipment in interstate commerce, at U-Haul Self Storage and stored to the account of Hillcrest Bank, the articles were adulterated in that they were devices which were classified, under 21 U.S.C. Section 360c(f), into class III, and there were no approved applications for premarket approval in effect pursuant to 21 U.S.C. Section 360e and no investigational device exemptions were in effect pursuant to 21 U.S.C. Section 360j(g)--501(f)(1)(B). The articles were misbranded in that they were prepared and processed in an establishment not duly registered under 21 U.S.C. Section 360, were not included in a list required by 21 U.S.C. Section 360(j), and were not covered by a notice or other information provided to FDA as required by 21 U.S.C. Section 360(k)--502(o).
DISPOSITION: The articles were destroyed pursuant to a default decree of condemnation, forfeiture and destruction. (F.D.C. No. 67254; S. No. 98-688-913; S.J. No. 2)

PRODUCT: Surgical Instrument Sterilizer Model MD-200, at Salt Lake City, Utah (D. Utah), Civil Action No. 2:95CV514G.
CHARGED 6-2-95: This was a seizure of the Surgical Instrument Sterilizer Model MD-200, located at Fritz Companies, Inc., in Salt Lake City, Utah. The article of device was adulterated in that it was a class III device under 21 U.S.C. 360c(f)(1) and did not have an approved application for premarket approval in effect pursuant to 21 U.S.C. 360e(a)(2) or an approved application for premarket approval in effect pursuant to 21 U.S.C. 360j(g)--501(f)(1)(B). The article was misbranded in that its labeling failed to bear adequate directions for use for the purposes for which it was intended, and the article was not exempt from the requirement of 21 U.S.C. 352(f)(1) under 21 C.F.R 801.109 because it was not labeled in accordance with 21 C.F.R 801.109--502(f)(1).
DISPOSITION: The article was destroyed. (F.D.C. No. 67092; S. No. 95-698- 508; S.J. No. 3)

INJUNCTION ACTIONS

DEFENDANTS: Amide Pharmaceuticals, Inc., a corporation, and Chandu Patel, an individual, at Little Falls, N.J. (D. N.J.); Civil No. 92-513.
CHARGED 3-2-92: On March 2, 1992, the U.S. District Court for the District of New Jersey entered a consent decree of injunction against Amide Pharmaceutical, Inc. On March 30, 1999, counsel for Amide Pharmaceutical, Inc., requested relief from the consent decree.
DISPOSITION: The District Court and the Center for Drug Evaluation and Research reviewed the firm's compliance history and concluded that the agency should not dissolve the consent decree at this time. On June 30, 1999, the district denied the firm's request for relief. (Inj. No. 1271A; S.J. No. 4)

DEFENDANTS: NED Enterprises, Inc., a corporation, doing business as Gulf Crab Co., and Nolan J. Dempster and Earline T. Dempster, individuals, at Des Allemands, La. (E.D. La.); Civil No. 95-0086.
CHARGED 1-9-95: While held for sale, after shipment in interstate commerce, at Gulf Crab Company, in Des Allemands, La., the article of food, crab meat, was adulterated in that it had been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth--402(a)(4). The article was further adulterated in that it consisted in whole or in part of a filthy substance, as demonstrated by the presence of Escherichia coli --402(a)(3).
DISPOSITION: On Jan. 22, 1996, the parties entered into a consent decree of permanent injunction, enjoining the defendants from directly or indirectly introducing or delivering for introduction into interstate commerce any article of food that had been received, processed, prepared, packed, or held at their plant. After a brief shutdown, the firm resumed operations, and a subsequent FDA inspection found substantial improvement in the firm's operations. Subsequently, however, for reasons unknown to FDA, the firm ceased operations. NED Enterprises, Inc., was dissolved on Dec. 22, 1997. (Inj. No. 1357; S. No. 94-689-955; S.J. No. 5)

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