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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.
PRODUCT: French Bread Crumbs, at Des Moines, Iowa (S.D. Iowa); Civil Action No. 4-97-CV-80301.
CHARGED 4-28-97: While held for sale after shipment in interstate commerce at Tone Brothers, Inc., Des Moines, Iowa, the articles were adulterated in that they consisted in part of a filthy substance, namely rodent urine, rodent nesting material, and rodent hair, and because they were rodent gnawed--402(a)(3). In addition, they were adulterated in that they had been held under insanitary conditions whereby they may have become contaminated with filth--402(a)(4).
DISPOSITION: The adulterated articles were destroyed, while salvageable food was reconditioned. (F.D.C. No. 67183; S. No. 97-722-306; S.J. No. 2)
PRODUCT: Olive Oil, at Long Island City, N.Y. (E.D. N.Y.); Civil Action No. CV 97-1183.
CHARGED 3-11-97: While held for sale after shipment in interstate commerce at Krinos Foods, Inc., in Long Island City, N.Y., the article was adulterated in that sunflower oil had been substituted in whole or in part for olive oil--402(b)(2). The article was misbranded in that it was offered for sale under the name of another food, namely pomace olive oil--403(b).
DISPOSITION: The article was reconditioned. (F.D.C. No. 67170; S. No. 96-753-290; S.J. No. 3)
PRODUCT: Red Beans and Corn Masa Mix, at Alexandria, Va. (E.D. Va.); Civil Action No. 94-1192A.
CHARGED 9-9-94: While held for sale, after shipment in interstate commerce, in the possession of Food Warehouse International, Inc., trading and doing business as Metropolitan Food, in Alexandria, Va., the articles were adulterated in that they had been held under insanitary conditions whereby they became contaminated with filth--402(a)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67011; S. No. 94-656-381; S.J. No. 4)
PRODUCT: Shrimp, at Orlando, Fla. (M.D. Fla.); Civil Action No. 97-2827-CIV-24A.
CHARGED 11-26-97: While held for sale after shipment in interstate commerce at Mercury Cold Storage, in Tampa, Fla., and stored to the account of Tampa Bay Fisheries, Inc., the articles were adulterated in that they consisted in part of a decomposed substance--402(a)(3).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67214; S. No. 97-712-439; S.J. No. 5)
PRODUCT: Oxygen, at Monroe, La. (W.D. La.); Civil Action No. CV 95-1349.
CHARGED 7-23-95: While held for sale after shipment in interstate commerce at Welding Supply, Inc., in Monroe, La., the articles of drug were adulterated in that the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and holding did not conform to and were not operated in conformity with good manufacturing practice (GMP) requirements of the Food, Drug, and Cosmetic Act--501(a)(2)(B). The articles of drug were misbranded in that their labeling failed to bear the statement "Caution: Federal law prohibits dispensing without a prescription," as required--503(b)(4).
DISPOSITION: The articles of drug were reconditioned. (F.D.C. No. 67097; S. No. 95-519-491; S.J. No. 7)
PRODUCT: Oxygen, at New Brighton, Pa. (W.D. Pa.); Civil Action No. 94-0743.
CHARGED 5-5-94: While held for sale after shipment in interstate commerce at Butler Gas Products Co., in New Brighton, Pa., the article of drug was adulterated in that the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and holding did not conform to and were not operated in conformity with good manufacturing practice (GMP) requirements of the Food, Drug, and Cosmetic Act--501(a)(2)(B).
DISPOSITION: The article of drug was reconditioned. (F.D.C. No. 66958; S. No. 93-607-680; S.J. No. 8)
PRODUCT: Yeast Gard, at Vernon Hills, Ill. (E.D. Ill.), Civil Action No. 97 C 4801.
CHARGED 7-7-97: While held for sale after shipment in interstate commerce at Lake Consumer Products, Inc., in Vernon Hills, Ill., the articles of drug were adulterated in that they were new drugs within the meaning of 201(p) and no approval of application filed pursuant to 505(b) was in effect for such drugs. The articles of drug were misbranded in that their labeling failed to bear adequate directions for use, and they were not exempt from such requirements, since the articles were unapproved "new drugs"--502(f)(1). In addition, the articles of drug were misbranded in that their labeling represented and suggested that the products were safe and effective in the treatment of vaginal yeast infections, but did not contain any ingredients that were generally recognized as safe and effective for such treatments--502(a).
DISPOSITION: Some of the articles were destroyed while others were reconditioned pursuant to the consent decree of permanent injunction. (F.D.C. No. 67010; S. No. 97-761-330; S.J. No. 9)
DEFENDANT: Barr Laboratories, Inc., a corporation, and Edwin A. Cohen, Gerald F. Price, and Ezzel-Din A. Hamza, individuals, at Pomana, N.Y. (S.D. N.Y.); Civil No. 92-CIV 4326(GLG) and at Northvale, N.J. (D. N.J.); Civil No. 92-2684.
CHARGED 6-12-92: Barr Laboratories, Inc., was a large manufacturer of generic drugs, headquartered in Pomana, N.Y., with manufacturing facilities there and in Northvale, N.J. The complaint was filed in the state of New York, and the case was transferred to the state of New Jersey, whereby the consent order was filed. While held for sale after shipment in interstate commerce at Barr Laboratories, Inc., in both Pomana, N.Y. and Northvale, N.J., the articles of drug were adulterated in that the facilities and controls used for the manufacture, processing, packing, labeling, and holding did not conform to and were not operated in conformity with the good manufacturing practice (GMP) requirements of the Food, Drug, and Cosmetic Act--501(a)(2)(B). In addition, the articles of drug were adulterated in that they were represented as drugs the names of which were recognized in an official compendium, and their strength differed from, or their quality or purity fell below, the standards set forth in such a compendium--501(b). The articles of drug were misbranded in that their labeling was false or misleading--502(a). Certain products manufactured and distributed by the defendants were unapproved new drugs because, while they were each the subject of an approved ANDA, defendants made changes in manufacturing conditions established in the ANDA applications without FDA approval of supplements to these ANDAs, as required, before the changes were implemented--505(J).
DISPOSITION: The U.S. District Court granted a consent order of injunction directing Barr to follow previously ordered procedures to validate the still unvalidated products. The Court also ordered Barr to submit a validation protocol plan for each drug's validation to FDA for pre-review prior to beginning the validation studies, and required Barr to obtain FDA's approval of the subsequent validation studies prior to release of the product. Barr was also ordered to pay costs of the inspections, examinations, reviews, and evaluations incurred by FDA personnel to monitor compliance with the Court's order, and also ordered Barr to pay the costs of evaluating the validation protocols and studies submitted by them pursuant to the Court's order. (Inj. No. 1275; S.J. No. 11)
DEFENDANT: Robert J. Diepersloot, an individual d/b/a Dutch Apple Farms Dairy, at Dinuba, Calif. (E.D. Calif.); Civil No. CVF-96-5304.
CHARGED 3-27-96: While held for sale after shipment in interstate commerce at Dutch Apple Farms Dairy, in Dinuba, Calif., the beef derived from cattle sold or offered for sale by Dutch Apple Farms Dairy was adulterated in that it contained residues of unsafe new animal drugs (or conversion products thereof)--402(a)(2)(D). In addition, the cattle sold for use as human food were adulterated because the defendant failed to adequately control and monitor the use of new animal drugs to treat the animals he held for slaughter, thereby holding food under insanitary conditions whereby it may have been rendered injurious to health--402(a)(4).
DISPOSITION: The U.S. District Court granted a consent decree of permanent injunction. The Court also ordered the defendant to pay costs for the investigational expenses incurred. (Inj. No. 1388; S.J. No. 12)
FDA Consumer magazine (January-February 1999)
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