Table of Contents
FDA Consumer magazine
September-October 2000
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.
PRODUCT: Articles of Food, Dusting Starch, at Norfolk, Va. (E.D. Va.); Civil Action No. 2:99cv1130.
CHARGED 7-16-99: While held for sale after shipment in interstate commerce at Golden Fields Enterprises, Inc., Norfolk, Va., the articles of food were adulterated in that they had been prepared, packed, and held under insanitary conditions whereby they might have become contaminated with filth--402(a)(4).
DISPOSITION: Pursuant to Default Decree of Condemnation, Forfeiture, and Destruction, the articles of food were destroyed Dec. 17, 1999. (F.D.C. No. 67278; S. No. 48739 et al.; S.J. No. 1)
PRODUCT: Beef trachea, 3 cases, more or less, at Greeley, Colo. (D. Colo.); Civil Action No. 99-Z-2398.
CHARGED 12-16-99: While held for sale after shipment in interstate commerce at Old West Treat Company, in Greeley, Colo., the article of food was adulterated in that it bore or contained Salmonella, a poisonous and deleterious substance which might have rendered it injurious to health--402(a)(1).
DISPOSITION: The article of food was destroyed. (F.D.C. No. 67296; S. No. 57883; S.J. No. 2)
PRODUCT: Canned mushrooms, 1000 cases more or less, at South San Francisco, Calif. (N.D. Calif.); Civil Action No. C-97-3234.
CHARGED 9-2-97: While held for sale after shipment in interstate commerce, at QFCO, Inc., doing business as Queensway Foods Co. Inc., in South San Francisco, Calif., the articles of food were misbranded in that their labeling was false and misleading because it contained a fictitious can code which falsely suggested that the mushrooms were packed by Gen Hong Foods Industrial Co. Ltd., and because it falsely represented and suggested that the mushrooms were grown in Taiwan--403(a)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67190; S. No. 97-753-988; S.J. No. 3)
PRODUCT: Extra Virgin Olive Oil, 618 cases more or less, at Riviera Beach, Fla. (S.D. Fla.); Civil Action No. 00-0014.
CHARGED 1-4-00: While held for sale after shipment in interstate commerce at Cheney Brothers, Inc., stored to the account of LFI, Inc., Fairfield, N.J., the articles of food were adulterated in that sunflower oil had been substituted in whole or in part for extra virgin olive oil (618 case lots); soybean oil had been substituted in whole or in part for olive pomace oil (160 case lots); and sunflower oil had been substituted in part for olive oil (86 case lots)--402(b)(2). The articles of food were misbranded because their labels falsely represented them as extra virgin olive oil, olive pomace oil, and pure olive oil--403(a)(1). The articles were further misbranded in that these mixtures of oils were largely sunflower or soybean oil, but were unlawfully offered for sale under the name of another food, namely, extra virgin olive oil, olive pomace oil, and pure olive oil --403(b).
DISPOSITION: The articles were destroyed May 23, 2000 pursuant to a default judgment. (F.D.C. No. 67299; S. No. 54822 et al.; S.J. No. 4)
PRODUCT: Frozen Shrimp, 1,192 cases more or less, at Jacksonville, Fla. (M.D. Fla.); Civil Action No. 98-236-Civ-J-20B.
CHARGED 3-16-98: While held for sale after shipment in interstate commerce at Industrial Cold Storage, Inc. and stored to the account of King and Prince Seafood Corporation in Brunswick, Ga., the articles of food were all adulterated in that they consisted in whole or in part of a decomposed substance by reason of the presence therein of decomposed shrimp--402(a)(3).
DISPOSITION: Pursuant to an order amending the consent decree, a portion of the defendant lot of decomposed frozen shrimp was satisfactorily reconditioned. The rejected portion of the reconditioned product had been destroyed under the supervision of the United States Marshals Service. (F.D.C. No. 67224; S. No. 98-712-573; S.J. No. 5)
PRODUCT: Frozen shrimp, 302 cases, more or less, at Tampa, Fla. (M.D. Fla.); Civil Action No. 98-476-CIV-T-17C.
CHARGED 3-4-98: While held for sale after shipment in interstate commerce at Americold Corporation, stored to the account of Central Seaway Company, Inc., in Tampa, Fla., all of the defendant shrimp were adulterated in that they consisted in whole or in part of a decomposed substance by reason of the presence therein of decomposed shrimp--402(a)(3). Furthermore, certain defendant shrimp (420 cases, more or less) were also adulterated in that they consisted in whole or in part of a filthy substance by reason of the presence therein of insect and bird filth--402(a)(3).
DISPOSITION: The condemned defendant shrimp was exported to Zhejiang Foreign Economic Relations and Trade Development Corporation, Hangzhou, China. (F.D.C. No. 67223; S. No. 98-768-226/228; S.J. No. 6)
PRODUCT: Preserved Turnip, 60 cases more or less, at Brooklyn, N.Y. (E.D. N.Y.); Civil Action No. 98-CV-0181.
CHARGED 1-14-98: While held for sale after shipment in interstate commerce at Yick Cheung Corporation, doing business as Goodworld Trading, in Brooklyn, N.Y., the articles of food were adulterated in that the articles (60 case lots of preserved turnips) consisted in part of a filthy substance, by reason of having been rodent-gnawed and by reason of the presence therein of rodent urine--402(a)(3). The articles were further adulterated in that they (all lots) had been held under insanitary conditions whereby they very likely became contaminated with filth--402(a)(4).
DISPOSITION: The condemned articles of food were successfully reconditioned. (F.D.C. No. 67222; S. No. 98-751-473; S.J. No. 7)
PRODUCT: Soybeans and Mung Beans, at San Lorenzo, Calif. (N.D. Calif.); Civil Action No. 99-4799.
CHARGED 11-1-99: While held for sale after shipment in interstate commerce at Dong Ling Sprout and Produce Co., in San Lorenzo, Calif., the articles of food were adulterated in that certain articles of food consisted in part of a filthy substance, including 350 50-pound bag lots of soybeans, by reason of being rodent gnawed; 720 55-pound bag lots of mung beans, by reason of the presence therein of insects and rodent excreta pellets; 1,190 110-pound bag lots of mung beans, by reason of the presence therein of rodent hairs; and 2,320 55-pound bag lots of mung beans, by reason of the presence therein of mammalian urine--402(a)(3). The articles were further adulterated in that all articles of food (all lots) had been held under insanitary conditions whereby they might have become contaminated with filth--402(a)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67290; S. No. 38938 et al.; S.J. No. 8)
PRODUCT: Straw Mushrooms, 836 cases more or less, at Brooklyn, N.Y. (E.D. N.Y.); Civil Action No. CV99-2475.
CHARGED 4-29-99: While held for sale after shipment in interstate commerce at S.D.J. Trading Corp., Brooklyn, N.Y., the article of food was misbranded in that its labeling was false and misleading because it contained a fictitious can code which falsely represented that the article was packed by the Zhang Zhou General Canned Food Factory, Zhang Zhou, People's Republic of China--403(a)(1).
DISPOSITION: The article was destroyed. (F.D.C. No. 67265; S. No. 42006; S.J. No. 9)
PRODUCT: Liquid Oxygen, at Manhattan, Kan. (D. Kansas); Civil Action No. 99-1269.
CHARGED 7-2-99: While held for sale after shipment of one or more of its components in interstate commerce, at Home-Ox of Kansas, Inc., the article of drug was adulterated in that the methods used in, and the facilities and controls used for, its manufacture, processing, packing and holding did not conform to, and were not operated and administered in conformity with, current good manufacturing practice (CGMP) requirements--501(a)(2)(B). The article was misbranded in that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under 21 U.S.C. Section 360, and the article had not been listed as required by 21 U.S.C. Section 360(j)--502(o).
DISPOSITION: The article was reconditioned. (F.D.C. No. 67271; S. No. DOC 30295, 56568; S.J. No. 10)
PRODUCT: Oxygen, at Owings Mills, Md. (D. Md.); Civil Action No. L-99-1326.
CHARGED 5-7-99: While held for sale after shipment of one or more components in interstate commerce at Professional Respiratory Services, Inc., the articles of drug were adulterated in that the methods used in and the facilities and controls used for their manufacture, processing, packing and holding did not confirm to, and were not operated and administered in conformity with, current good manufacturing practice requirements of the Food, Drug and Cosmetic Act--501(a)(2)(B). The article (cryogenic home units) was misbranded in that its label failed to bear the name and place of business of the manufacturer--502(b)(1). The article (cryogenic home units) was also misbranded in that its label failed to bear an accurate statement of the quantity of contents--502(b)(2). The article (cryogenic home units) was misbranded in that its label failed to bear adequate directions for use--502(f)(1). The articles were further misbranded in that their labels failed to bear, at a minimum, the symbol "Rx only"--353(b)(4)(A).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67264; S. No. DOC 19721/22; S.J. No. 11)
PRODUCT: Oxygen, at Shreveport, La. (W.D. La.); Civil Action No. CV99-0946.
CHARGED 5-27-99: While held for sale after shipment of one or more of their components in interstate commerce at Red Ball Oxygen Company, Inc., in Shreveport, La., the articles of drug 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--501(a)(2)(B). Furthermore, the articles (Oxygen USP and Nitrogen UF in cryogenic vessels) were misbranded in that they failed to bear labels containing the name and place of business of the manufacturer--502(b)(1).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67267; S. No. DOC 19131; S.J. No. 12)
PRODUCT: Topical Products for Skin Diseases, at Miami, Fla. (S.D. Fla.); Civil Action No. 99-2721.
CHARGED 10-18-99: While held for sale after shipment in interstate commerce at Ameritrade Beauty Care, Inc., in Miami, Fla., the articles of drug were misbranded in that their labeling failed to bear adequate directions for use and they were not exempt from such requirement under 21 C.F.R. Section 201.115, since the articles were unapproved new drugs--502(f)(1). The articles were also misbranded in that they had not been duly listed as required by 21 U.S.C. Section 360(j)--502(o). The articles were further misbranded in that their labels failed to bear, at a minimum, the symbol "Rx only"--503(b)(4)(A).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67288; S. No. 41344 et al.; S.J. No. 13)
PRODUCT: Various topical products, at Miami, Fla. (S.D. Fla.); Civil Acton No. 99-2777.
CHARGED 10-18-99: While held for sale after shipment in interstate commerce at Victoria Beauty Supplies, in Miami, Fla., the articles of drug were misbranded in that their labeling failed to bear adequate directions for use and they were not exempt from such requirement under 21 C.F.R. Section 201.115, since the articles were unapproved new drugs--502(f)(1). The articles were also misbranded in that they had not been duly listed as required by 21 U.S.C. Section 360(j)--502(o). Moreover, the articles were misbranded in that their labels failed to bear, at a minimum, the symbol "Rx only"--503(b)(4)(A).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67287; S. No. 52095 et al.; S.J. No. 14)
PRODUCT: Various Topical Products for Skin Diseases, at Miami, Fla. (S.D. Fla.); Civil Action No. 99-2779.
CHARGED 10-18-99: While held for sale after shipment in interstate commerce at Victoria Wholesale, Inc., in Miami, Fla., the articles of drug were misbranded in that their labeling failed to bear adequate directions for use and they were not exempt from such requirement under 21 C.F.R. Section 201.115, since the articles were unapproved new drugs--502(f)(1). The articles were also misbranded in that they had not been duly listed as required by 21 U.S.C. Section 360(j)--502(o). The articles were further misbranded in that their label failed to bear, at a minimum, the symbol "Rx only"--503(b)(4)(A).
DISPOSITION: The articles were destroyed. (F.D.C. 67286; S. No. 52095 et al.; S.J. No. 15)
PRODUCT: Surgical Sutures and Various Surgical Devices, at Tampa, Fla. (M.D. Fla.); Civil Action No. 98-2363-Civ-T-26 (C).
CHARGED 11-18-98: While held for sale after shipment in interstate commerce at EcuAmerica International, in Tampa, Fla., the articles of devices were adulterated in that they were held under insanitary conditions whereby they might have become contaminated with filth or might have been rendered injurious to health--501(a)(2)(A). The articles were further adulterated in that their purity and quality fell below that which they purported and were represented to possess--501(c). The articles were misbranded in that they were in package form and their labels failed to bear the name and place of business of the company distributing the devices--502(b)(1). The articles were further misbranded in that their labeling was false and misleading because it failed to reveal the material facts that the manufacturer had inspected the devices and concluded that they had been rejected after undergoing a United States Surgical Corporation quality audit and that they were not fit for use or sale under any circumstances--502(a).
DISPOSITION: Pursuant to a default judgment entered 7-21-99, the articles were destroyed. (F.D.C. No. 67239; S. N. 98-800-025/9; S.J. No. 16)
DEFENDANT: National Medical Care, at Rockleigh, N.J. (D. N.J.); Civil Action No. 99-748.
CHARGED 12-22-99: On Dec. 22, 1999, the defendant, now a division of Fresenius Medical Care North America, appeared in the United States District Court for the District of New Jersey and pleaded guilty to two misdemeanor charges: (1) distribution in interstate commerce of devices that were adulterated because they were not manufactured in accordance with current good manufacturing practices; and (2) the failure to file medical device reports. NMC Medical Products admitted that from December 16, 1992, to Oct. 6, 1993, it released into interstate commerce adulterated bloodlines, the tubes that carry a dialysis patient's blood to and from the patient and a dialyzer (artificial kidney), even though its own tests showed the bloodlines were prone to develop potentially excessive levels of air bubbles as they carried the patients' blood. After it released the adulterated bloodlines, the company received four reports of serious injury caused by the devices, and 108 malfunctions during dialysis. The company also admitted that it failed to report in a timely manner 1,196 incidents in which its devices, such as dialyzers, bloodlines, and related products, may have caused or contributed to a death or serious injury or may have malfunctioned. The company admitted that it made those reports only after the company received a federal grand jury subpoena calling for their production.
DISPOSITION: The court ordered NMC Medical Products, Inc. to pay a fine of $3,800,000, the highest fine ever imposed for a misdemeanor violation of the Federal Food, Drug, and Cosmetic Act. (Pros. No. 66868; S.J. No. 17)
DEFENDANT: Cape Fear Valley Medical Center, Roy A. Weaver and John E. Strickland, at Fayetteville, N.C. (E.D. N.C.); Civil Action No. 93-105-Civ-3-H.
CHARGED 11-17-93: While held for sale after shipment of one or more of their components in interstate commerce, the articles of drug, blood products, were adulterated in that the defendants failed to comply with the current good manufacturing practice (CGMP) regulations for drugs, 21 C.F.R. Parts 210 and 211, and the CGMP regulations for blood and blood products, 21 C.F.R. Part 606, in collecting, manufacturing, processing, testing, packing, labeling, holding, or distributing of such articles of drug--501(a)(2)(B).
DISPOSITION: The Court entered a consent decree of permanent injunction on Nov. 23, 1993. Defendant Cape Fear Valley operated under the consent decree for several years and made several corrections and changes to its operation. On Jan. 4, 2000, Defendants moved to vacate the injunction, and the government did not oppose the motion. On Jan. 11, 2000, the U.S. District Court (E.D. N.C.) issued an order vacating the injunction. (Inj. 1342; S. No. 93-696-712; S.J. No. 18)
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