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: Claw crabmeat, frozen, at Belhaven, N.C. (E.D.N.C.); Civil Action No. 4:95-CV-137-H-1.
CHARGED 12-26-95: While held for sale after shipment in interstate commerce at Sea Safari, Ltd., in Belhaven, N.C., the article was adulterated in that it consisted of decomposed crabmeat--402(a)(3).
DISPOSITION: A consent decree of condemnation and destruction ordered the article destroyed. (F.D.C. No. 67117; S. No. 96-655-058; S.J. No. 1)

PRODUCT: Infant formula, at Brooklyn, N.Y. (E.D.N.Y.); Civil Action No. CV-96-1687.
CHARGED 4-9-96: While held for sale after shipment in interstate commerce at Sunset Merchandising, Inc., in Brooklyn, N.Y., the article was adulterated in that it did not contain the required nutrient inositol--412(a)(1). The article was also adulterated in that it failed to bear a lot code--412(a)(3). The article was misbranded in that it was represented to be for special dietary use because the label stated that the product was infant formula--403(j). The article was also misbranded in that the label failed to bear nutrient information, a statement of the number of fluid ounces supplying kilocalories, a statement of the amount of each of several nutrients supplied by 100 kilocalories, and the weight and volume of powdered formula to be reconstituted--403(j).
DISPOSITION: A default decree of condemnation and destruction ordered the article destroyed. (F.D.C. No. 67136; S. No. 96-752-707; S.J. No. 2)

PRODUCT: Shrimp, frozen, at Los Angeles, Calif. (C.D. Calif.); Civil Action No. 94-4660-JSL.
CHARGED 7-12-94: While held for sale after shipment in interstate commerce at Los Angeles Cold Storage in Los Angeles, Calif., the articles were adulterated in that they consisted of decomposed shrimp--402(a)(3).
DISPOSITION: A consent decree of condemnation ordered the articles destroyed. (F.D.C. No. 66995; S. No. 94-713-500; S.J. No. 3)

PRODUCT: Shrimp, frozen, at St. Petersburg, Fla. (M.D. Fla.); Civil Action No. 94-1386-Civ-T-23(C).
CHARGED 10-6-94: While held for sale after shipment in interstate commerce at Sigma International, Inc., in St. Petersburg, Fla., the articles were adulterated in that they consisted of decomposed shrimp--402(a)(3).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67009; S. No. 94-681-792; S.J. No. 4)

PRODUCT: Smoked sprats, at Brooklyn, N.Y. (E.D.N.Y.); Civil Action No. CV 95-2406.
CHARGED 6-14-95: While held for sale after shipment in interstate commerce at International Gold Star Trading Company, in Brooklyn, N.Y., the articles were adulterated in that they were prepared and packed under conditions whereby they might have been rendered injurious to health--402(a)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67087; S. No. 94-752-104; S.J. No. 5)

Drugs/Human Use

PRODUCT: Oxygen, at Butler, Pa. (W.D. Pa.); Civil Action No. 94-620.
CHARGED 4-15-94: While held for sale after shipment in interstate commerce at Medi-Home-Care in Butler, Pa., 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).
DISPOSITION: A consent decree of condemnation ordered the articles destroyed. (F.D.C. No. 66904; S. No. 93-607-839; S.J. No. 6)

PRODUCT: Oxygen, at Virginia Beach, Va. (E.D. Va.); Civil Action No. 2:96CV382.
CHARGED 4-17-96: While held for sale after shipment in interstate commerce at Liberty Home Health Care, d/b/a Oxygen Specialties in Virginia Beach, Va., 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 the required statement "Caution: Federal law prohibits dispensing without prescription"--503(b)(4).
DISPOSITION: A consent decree of condemnation ordered the articles destroyed. (F.D.C. No. 67133; S. No. 96-703-958; S.J. No. 7)

PRODUCT: Oxygen, at Monona, Wis. (W.D. Wis.); Civil Action No. 96C-744-S.
CHARGED 8-27-96: While held for sale after shipment in interstate commerce at Apria Healthcare, Inc., in Monona, Wis., 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 requirements--501(a)(2)(B).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67146; S. No. 96-719-113; S.J. No. 8)

PRODUCT: Topical creams and gels, at Miami Lakes, Fla. (S.D. Fla.); Civil Action No. 94-2507-CIV-Marcus.
CHARGED 11-23-94: While held for sale after shipment in interstate commerce at Tex International, Inc., in Miami Lakes, Fla., the articles were new drugs without an approved application--505(a). The articles were misbranded in that their labels failed to bear the established names of the drugs, and they failed to bear adequate directions for use--502(e)(1)(A)(i) and 502(f)(1). The articles were also misbranded in that they were not duly listed as required, and their labels failed to bear the statement "Caution: Federal law prohibits dispensing without a prescription"--502(o) and 503(b)(4).
DISPOSITION: A consent decree of condemnation, destruction and re-exportation was filed. Some of the articles were destroyed, and the others were exported to Italy. (F.D.C. No. 67030; S. No. 94-682-308; S.J. No. 9)

Medical Devices

PRODUCT: Acu-Stop 2000, ear pieces, at Coral Springs, Fla., and Boca Raton, Fla. (S.D. Fla.); Civil Action No. 94-7021-CIV.
CHARGED 10-21-94: While held for sale after shipment in interstate commerce at Original Marketing, Inc., in Coral Springs, Fla., and at the Habilitation Center for the Handicapped, in Boca Raton, Fla., the articles were adulterated in that they were class III devices without an approved application for premarket approval--501(f)(1)(B). The articles were misbranded in that they were manufactured in an establishment that was not duly registered--502(o).
DISPOSITION: A consent decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 66976; S. No. 94-682-497; S.J. No. 10)

CIVIL MONEY PENALTIES

DEFENDANTS: DeHaven & Associates, d/b/a SMS Services, Inc., and John K. DeHaven, at New Orleans, La. (E.D. La.); Civil Action No. 95-1177.
CHARGED 4-13-95: The defendants failed to submit the required reports after assembling, installing and delivering diagnostic x-ray systems--538(a)(4). The defendants failed to repair, replace, or refund the cost of the x-ray systems that were not in compliance--538(a)(2).
DISPOSITION: The defendants were ordered to pay $13,000 in civil penalties and enjoined from further violations. (F.D.C. No. 66854; S. No. 94-689-994; S.J. No. 11)

CRIMINAL ACTIONS

DEFENDANTS: BTC Corporation and Robert L. Chan, at Fairfield, Calif. (E.D. Calif.); Criminal No. CR-S-94-080 DFL.
CHARGED 3-4-94: Count 1: Defendant Chan, a manufacturer of diagnostic kits, willfully conspired to defraud FDA by impeding its lawful function of regulating the manufacture and distribution of certain types of diagnostic kits--18 U.S.C. section 371.
Counts 2 and 3: Defendant Chan knowingly caused an employee of BTC Corporation to create a laboratory notebook that omitted all data and references to the manufacture of certain types of diagnostic kits--18 U.S.C. sections 1001 and 2.
Count 4: Defendant Chan knowingly made a material false statement to an FDA official--18 U.S.C. sections 1001 and 2.
Count 5: Defendant Chan instructed a BTC employee to remove from its premises chemical solutions used in the manufacture of certain types of diagnostic kits in order to obstruct an ongoing administrative proceeding by FDA--18 U.S.C. sections 1505 and 2.
DISPOSITION: Defendant Chan pleaded guilty to count five. He was sentenced to six months of imprisonment and 24 months of supervised release, and was ordered to pay a $50 special assessment. (F.D.C. No. 66804; S.J. No. 12)

FDA Consumer magazine (May-June 1997)