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: Dog food, at Chicago, Ill. (N.D. Ill.); Civil Action No. 94C-1658.
CHARGED 3-17-94: While held for sale after shipment in interstate commerce at Freight-A-Ranger, Inc., in Chicago, Ill., the article was adulterated in that it consisted of rodent hairs, rodent excreta pellets, and rodent-gnawed paper--402(a)(3). The article was also adulterated in that it was held under insanitary conditions whereby it might have become contaminated with filth--402(a)(4).
DISPOSITION: A consent decree of condemnation and destruction ordered the article destroyed. However, the claimant turned the article into a component of animal feed and sold it. The claimant was ordered to pay for damages. (F.D.C. No. 66945; S. No. 94-740-806; S.J. No. 1)

PRODUCT: Olive oil, at Miami, Fla. (S.D. Fla.); Civil Action No. 96-1834 CIV-Davis.
CHARGED 7-3-96: While held for sale after shipment in interstate commerce at Greco-Roman, Inc., in Delray Beach, Fla., the article was adulterated in that canola oil was substituted for olive oil--402(b)(2). The article was misbranded in that the name on its labeling was false and misleading--403(a)(1).
DISPOSITION: A consent decree of condemnation and destruction ordered the article destroyed. (F.D.C. No. 67144; S. No. 96-683-103; S.J. No. 2)

PRODUCT: Rice, enriched, at Beltsville, Md. (D. Md.); Civil Action No. WMN-95-4022.
CHARGED 12-29-95: While held for sale after shipment in interstate commerce at Chung Wah Noodle Company in Beltsville, Md., the articles were adulterated in that they were held under insanitary conditions whereby they might have become contaminated with filth--402(a)(4).
DISPOSITION: A consent decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 67121; S. No. 96-656-364; S.J. No. 3)

Drugs/Human Use

PRODUCT: Guarana, capsules, at Albany, Ga. (M.D. Ga.); Civil Action No. 93-56-ALB-AMER.
CHARGED 5-13-93: While held for sale after shipment in interstate commerce at Bill's Wholesale Warehouse, Inc., in Albany, Ga., the articles were adulterated in that they were new drugs without an approved application--505(a). The articles were misbranded in that their labeling failed to bear adequate directions for use--502(f)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66699; S. No. 93-700-038; S.J. No. 4)

PRODUCT: Oxygen, at Monroe, La. (W.D. La.); Civil Action No. CV95-1349.
CHARGED 7-28-95: While held for sale after shipment in interstate commerce at Greene Welding Supply, Inc., in Monroe, La., the articles were adulterated in that the methods used in, and the facilities and controls used for, their manufacture, processing, packing, and holding were not in conformity with current good manufacturing practice requirements--501(a)(2)(B). The articles were misbranded in that their labeling failed to bear a warning statement--503(b)(4).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67139; S. No. 96-763-219; S.J. No. 5)

Medical Devices

PRODUCT: Intraocular lenses, at Largo, Fla. (M.D. Fla.); Civil Action No. 93-2009-Civ-T-24A.
CHARGED 12-17-93: While held for sale after shipment in interstate commerce at IOL International, Inc., in Largo, Fla., the articles were adulterated in that they were classified as class III devices without an application for premarket approval--501(f)(1)(B). The articles were also adulterated in that the methods used in, and the facilities and controls used for, their manufacture, packing and storage were not in conformity with current good manufacturing practice requirements--501(h). The articles were misbranded in that the labeling falsely represented they were investigational devices--502(a).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66768; S. No. 93-682-750; S.J. No. 6)

PRODUCT: Source plasma, at Abbott Park, Ill. (N.D. Ill.); Civil Action No. 94C 1219.
CHARGED 2-28-94: While held for sale after shipment in interstate commerce at Abbott Laboratories Diagnostic Division in Abbott Park, Ill., the articles were adulterated in that the methods used in, and the facilities and controls used for, their manufacture, packing, and storage were not in conformity with current good manufacturing practice requirements--501(h). The articles were misbranded in that the labeling falsely implied that the products were licensed and suitable for use in manufacturing when, in fact, they were not licensed or suitable for manufacturing--502(a). The articles were also misbranded in that their labeling failed to bear the name and location of the manufacturer and the proper article name and other required information--502(c).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66925; S. No. 94-661-765; S.J. No. 7)

PRODUCT: Sterilizing solution, at Jonesborough, Tenn. (E.D. Tenn.); Civil Action No. CIV 2-91-416.
CHARGED 12-13-91: While held for sale after shipment in interstate commerce at Chem-Mix, Inc., in Jonesborough, Tenn., the articles were adulterated in that their quality differed from that which they represented to possess--501(c). The articles were misbranded in that they presented a danger to health when used in the dosage, manner, frequency, or duration prescribed in their labeling--502(j). The articles were also misbranded in that their labeling was false and premarket notifications were not provided as required--502(a) and 502(o).
DISPOSITION: A consent decree ordered the articles destroyed. (F.D.C. Nos. 66265 and 66263; S. No. 91-585-880; S.J. No. 8)

FDA Consumer magazine (April 1997)