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: Betel Nuts, dried and sliced, at Chicago, Ill. (N.D.Ill.); Civil No. 95-C-4903.
CHARGED 8-25-95: While held for sale after shipment in interstate commerce at Lien Hoa Food Corp., in Chicago, Ill., the articles were adulterated in that they contained a poisonous and deleterious substance--402(a)(1).
DISPOSITION: A default decree of condemnation, forfeiture and destruction ordered the articles destroyed. (F.D.C. No. 67100; S. No. 95-741-549; S.J. No. 1)

PRODUCT: Lobster Tails, frozen, at Miami, Fla. (S.D.Fla.); Civil No. 95-616-CIV-Ungaro-Benages.
CHARGED 3-27-95: While held for sale after shipment in interstate commerce at Preferred Freezer Services, Inc., in Miami, Fla., the articles were adulterated in that they consisted of decomposed lobster tails--402(a)(3).
DISPOSITION: A consent decree for reexport authorized the release of the goods for reexportation. (F.D.C. No. 67075; S. No. 95-711-238; S.J. No. 2)

PRODUCT: Mushrooms, canned, at Jacksonville, Fla. (M.D.Fla.); Civil No. 95-106-CIV-J-20.
CHARGED 2-3-95: While held for sale after shipment in interstate commerce at Grimes Distribution Services, in Jacksonville, Fla., the articles were misbranded in that their labeling falsely represented that the articles were packed and grown in Taiwan--403(a)(1).
DISPOSITION: A default decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 67042; S. No. 93-682-700; S.J. No. 3)

PRODUCT: Prune Culls, at Cheektowaga, N.Y. (W.D.N.Y.); Civil No. 94-CV-0144.
CHARGED 2-25-94: While held for sale after shipment in interstate commerce at Allied Frozen Storage, Inc., in Cheektowaga, N.Y., the articles were adulterated in that they consisted of insects, insect parts, insect pupae, insect larvae, insect webbing, and insect excreta--402(a)(3).
DISPOSITION: A consent decree of condemnation, forfeiture and destruction ordered the articles destroyed. (F.D.C. No. 66908; S. No. 93-673-113; S.J. No. 4)

PRODUCT: Scallops, at Gretna, La. (E.D.La.); Civil No. 95-0604 Sect. SMAG.5.
CHARGED 2-21-95: While held for sale after shipment in interstate commerce at Gulf Atlantic Cold Storage, Inc., in Gretna, La., the articles were adulterated in that they consisted of a decomposed substance--402(a)(3).
DISPOSITION: A default decree ordered the articles destroyed. (F.D.C. No. 67065; S. No. 95-745-218; S.J. No. 5)

Drugs/Human Use

PRODUCT: Oxygen USP, at Tulsa, Okla. (N.D.Okla.); Civil No. 93-C 840B.
CHARGED 9-16-93: While held for sale after shipment in interstate commerce at American Respiratory, Inc., in Tulsa, Okla., the article 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 requirements--501(a)(2)(B). The article was misbranded in that its labeling failed to bear the name and place of business of the manufacturer, packer or distributor--502(b)(1). The article was also misbranded in that its labeling failed to contain a statement of the quantity of contents and adequate directions for its intended use--502(b)(2) and 502(f)(1).
DISPOSITION: A consent decree of condemnation and reconditioning was filed. The articles were reconditioned and brought into compliance. (F.D.C. No. 66758; S. No. 93-687-401; S.J. No. 6)

Medical Devices

PRODUCT: Bandages, conforming stretch gauze, at Mundelein, Ill. (N.D.Ill.); Civil No. 94C-4505.
CHARGED 7-25-95: While held for sale after shipment in interstate commerce at Medline Industries, Inc., in Mundelein, Ill., the articles were adulterated in that they were contaminated with mold, yeast and bacteria--501(c). The articles were misbranded in that their labeling falsely represented them as sterile--502(a).
DISPOSITION: A consent decree of condemnation was filed. The articles were reexported to Germany under agency supervision. (F.D.C. No. 66999; S. No. 94-710-913; S.J. No. 7)

PRODUCT: Eye Cleaners and Disinfectants, at San Jose, Calif. (N.D.Calif.); Civil No. C-94-20711.
CHARGED 10-7-94: While held for sale after shipment in interstate commerce at Lobob Laboratories, in San Jose, Calif., the articles were adulterated in that the methods used in, and the facilities and controls used for, their manufacturing, packing and storage were not in conformity with current good manufacturing practice requirements--501(h).
DISPOSITION: A default decree of condemnation, forfeiture and destruction ordered the articles destroyed. (F.D.C. No. 67008; S. No. 94-705-815; S.J. No. 8)

PRODUCT: Frequency Generators and Cosmic and Magnetic Polarizers, at San Diego, Calif. (S.D.Calif.); Civil No. 93-0230S.
CHARGED 2-12-93: While held for sale after shipment in interstate commerce at Crane Foundation, in San Diego, Calif., the articles were adulterated in that they were class III devices without an application for premarket approval--501(f)(1)(B). The articles were misbranded in that their labeling represented the articles as effective for treating cancer, AIDS, heart disease, arthritis, diabetes, infections, burns, and pain--502(a). The articles were also misbranded in that their labeling failed to bear adequate directions for use, and they were not manufactured in a duly registered establishment--502(f)(1) and 502(o).
DISPOSITION: An order of summary judgment, condemnation and destruction was filed, and the articles were destroyed. (F.D.C. No. 66496; S. No. 92-641-318; S.J. No. 9)

CRIMINAL ACTIONS

DEFENDANT: John Bushow, at St. Croix, U.S. Virgin Islands (D.Md.); Criminal No. HAR-91-0330.
CHARGED 9-6-91: The defendant, with the intent to mislead, failed to establish and maintain accurate batch production records--301(e). The defendant also failed to comply with current good manufacturing practice requirements in that he directed employees to manufacture a drug product following production procedures different from the process approved by FDA--301(e). He also directed employees to prepare and maintain production batch records which falsely stated that the approved mixing procedures were utilized--333(a)(2).
DISPOSITION: Guilty plea; sentenced to four months of prison, four months of parole, and ordered to pay a $50 special assessment. (F.D.C. No. 66528; S.J. No. 10)

DEFENDANT: Steve Colton, at Springfield, N.Y. (D.Md.); Criminal No. HAR-91-0125-R.
CHARGED 4-24-91: Counts 1-3: The defendant knowingly made a false statement to FDA in that he filed a bioequivalency study claiming it compared a generic drug product to the innovator product when the generic drug product was disguised as the innovator product--18 U.S.C. sections 2 and 1001.
DISPOSITION: Guilty plea; sentenced to 27 months of prison, fined $150, and debarred from providing any services in any capacity to a person with an approved or pending drug product application. (F.D.C. No. 66529; S.J. No. 11)

DEFENDANTS: Cypress Seafood Processors and Bethel Dyson, at Abbeville, La. (W.D.La.); Criminal No. CR-95-60017-01-02.
CHARGED 4-10-95: Counts 1-3: The defendants introduced adulterated food into interstate commerce--402(a)(4). The food was adulterated in that it was prepared, packed and held under insanitary conditions whereby it might have been contaminated with filth or rendered injurious to health--301(a) and 402(a)(4).
DISPOSITION: Cypress Seafood Processors, Inc., was sentenced to three years of probation and fined $2,500. Bethel Dyson, president of Cypress Seafood Processors, Inc., was sentenced to three years of probation and fined $3,000. (F.D.C. No. 66824; S.J. No. 12)

INJUNCTION ACTIONS

DEFENDANT: Frank Lampley, at Glenmoore, Pa. (E.D.Pa.); Civil No. 91-8023.
CHARGED 12-31-91: The defendant distributed adulterated and misbranded animal drugs in interstate commerce--301(a). The animal drugs were adulterated in that they were new drugs without an approved new drug application--501(a)(5). Some of the animal drugs were misbranded in that their labels did not contain a list of active ingredients--501(e)(1)(A).
DISPOSITION: A permanent injunction was filed and granted. The defendant appealed the decision to the U.S. Court of Appeals for the Third Circuit, which affirmed the district court's decision. (Inj. No. 1274; S. No. 90-611-703/704; S.J. No. 13)

MISCELLANEOUS ACTIONS

ACTION: U.S. v. Floyd E. Weston, at Sacramento, Calif. (E.D.Calif.); Civil Action No. CR-S 93-517 GGH.
CHARGED 3-22-94: The defendant pleaded guilty to a misdemeanor count for introducing unapproved medical devices into interstate commerce. The plea agreement required the defendant to agree to a permanent injunction barring him from selling the device or homeopathic remedies--301(a).
DISPOSITION: A consent decree of permanent injunction was filed. (Misc. No. 1073; S.J. No. 14)

FDA Consumer magazine (March 1996)