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: Lobster Tails, at Miami, Fla. (S.D.Fla.); Civil No. 95-0140.
CHARGED 1-25-95: While held for sale after shipment in interstate commerce at Emerald Fisheries, Inc., in Miami, Fla., the articles were adulterated in that they consisted of decomposed lobster tails--402(a)(3).
DISPOSITION: A consent decree authorized the release of the goods for reexportation to the original foreign vendor. (F.D.C. No. 67059; S. No. 95-735-458; S.J. No. 1)

PRODUCT: Mussels, canned in brine, at Los Angeles, Calif. (C.D.Calif.), Civil No. 95-4878 DT.
CHARGED 7-24-95: While held for sale after shipment in interstate commerce at G & K Sales in Los Angeles, Calif., the articles were adulterated due to rancidity and texture breakdown--402(a)(3).
DISPOSITION: A default judgment ordered the articles destroyed. (F.D.C. No. 67096; S. No. 95-713-949; S.J. No. 2)

PRODUCT: Shrimp, frozen, at Miami, Fla. (S.D.Fla.); Civil No. 94-1970.
CHARGED 9-21-94: While held for sale after shipment in interstate commerce at Northwestern Meat, Inc., in Miami, Fla., the articles were adulterated in that they contained insects, rodent hair, and cat or dog hair--402(a)(3).
DISPOSITION: A default decree of condemnation ordered the articles destroyed. (F.D.C. No. 66961; S. No. 94-595-108; S.J. No. 3)

PRODUCT: Shrimp, frozen, at Mobile, Ala. (S.D.Ala.); Civil No. 93-0530-CB-C.
CHARGED 6-23-93: While held for sale after shipment in interstate commerce at Christian Salvesen Cold Storage in Mobile, Ala., the articles were adulterated in that they consisted of decomposed shrimp--402(a)(3).
DISPOSITION: A consent decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 66734; S. No. 93-575-037; S.J. No. 4)

CRIMINAL ACTIONS

DEFENDANT: Duramed Pharmaceutical, at Cincinnati, Ohio (D.Md.); Civil No. HAR-30-0207.
CHARGED 5-24-93: Counts 1 and 3: The defendant introduced into interstate commerce unapproved new drugs that were manufactured with data generated on different product formulas from those requested on the approved new drug application--301(d) and 303(a)(1). Count 2: The defendant introduced into interstate commerce an adulterated drug. The drug was adulterated in that the defendant made a material change in the coating procedures of the product without obtaining approval from FDA--301(a) and 303(a)(1).
DISPOSITION: Guilty plea; entered into a consent decree of permanent injunction and ordered to pay a $500,000 fine. (F.D.C. No. 66101; S.J. No. 5)

INJUNCTION ACTIONS

DEFENDANTS: Kabi Pharmacia, Inc. and Anders Wiklund, at Piscataway, N.J. (D.N.J.); Civil No. 93-3199 (JWB).
CHARGED 7-19-93: The defendants introduced into interstate commerce a misbranded and unapproved new drug--301(a) and (d). The defendants also caused the drug to be misbranded while held for sale after shipment in interstate commerce--301(k).
DISPOSITION: A consent decree of permanent injunction was filed and granted. (Inj. No. 1339; S.J. No. 6)

DEFENDANTS: Maple Island, Inc., Daniel W. O'Brien, and Ronald B. Zirbel, at Wanamingo, Minn. (D.Minn.); Civil No. 4-93-789.
CHARGED 8-17-93: While held for sale at Maple Island, Inc., in Wanamingo, Minn., infant and special nutritional dietary formulas were adulterated in that they were manufactured, prepared, processed, packaged, and held for sale under insanitary conditions whereby they might have been contaminated with filth or rendered injurious to health--402(a)(4). The articles were also adulterated in that they contained Salmonella bacteria which might have rendered them injurious to health--402(a)(1). Defendants caused the adulterated articles to be introduced into interstate commerce--301(a). The defendants also manufactured, processed, packaged, prepared, and held the articles for sale after one or more of their components were shipped in interstate commerce--301(k).
DISPOSITION: Several products were recalled and destroyed. Defendants entered into a consent decree and resumed business upon compliance. (Inj. No. 1332; S. No. 93-658-050; S.J. No. 7)

DEFENDANTS: Tuente Livestock, Ronald W. Tuente, and Roger B. Tuente, at Yorkshire, Ohio (S.D. Ohio); Civil No. C-3-94-336.
CHARGED 8-15-94: The defendants caused adulterated swine to be introduced into interstate commerce--301(a) and 512(a)(1). The swine were adulterated in that they contained the presence of an unsafe new animal drug--402(a)(2)(D).
DISPOSITION: The defendants entered into a consent decree in which they agreed to surrender their livestock dealing licenses and to withdraw from the livestock dealing trade for six years. (Inj. No. 1351; S. No. 94-708-236; S.J. No. 8)

MISCELLANEOUS ACTIONS

ACTION: Schering Corporation v. FDA, at Kenilworth, N.J. (D.N.J.); Civil No. 93-3493 (HLS).
CHARGED 8-10-93: Plaintiff challenged a regulation implementing the bioequivalence requirements for generic drugs under the abbreviated application procedure. Plaintiff claimed the regulation impermissibly broadened the statutory definition of bioequivalence.
DISPOSITION: The district court granted a summary judgment in favor of FDA. The appellate court affirmed the district court's decision. Plaintiff filed a petition for certiorari which was denied. (Misc. No. 1003; S.J. No. 9)

FDA Consumer magazine (April 1996)