Summaries of Court Actions

FDA Consumer, September 1999 | Go to article overview

Summaries of Court Actions


SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Shrimp, frozen, 1,493 cases, more or less, at Brownsville, Texas (S.D. Tex.); Civil Action No. B-95-017.

CHARGED 1-27-95: While held for sale after shipment in interstate commerce at Tex-Mex Cold Storage, Inc., in Brownsville, Texas, the article of food was adulterated in that it consisted in whole or in part of decomposed shrimp.

DISPOSITION: The article was destroyed. (F.D.C. No. 67036; S. No. 94-666-541; S.J. No. 1)

Drugs/Human Use

PRODUCT: Oxygen, at Sandusky, Ohio (N.D. Ohio); Civil Action No. 3:97CV7704.

CHARGED 10-28-97: While held for sale after shipment of one or more of its components in interstate commerce at Seeley Medical, Inc., in Sandusky, Ohio, 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--501(a)(2)(B). The article of drug was misbranded in that its labeling failed to bear the statement "Caution: Federal law prohibits dispensing without prescription"--503(b)(4).

DISPOSITION: The article was reconditioned. FDA costs were paid and bond was released. (F.D.C. No. 67205; S. No. 97-765-575; S.J. No. 2)

PRODUCT: Oxygen, Liquid Medical, at Cumberland, Md. (D. Md.); Civil Action No. CCB 98-3410.

CHARGED 10-9-98: While held for sale after shipment of one or more of its components in interstate commerce at American Homepatient, Inc., in Cumberland, Md., 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 were not in conformity with current good manufacturing practice--501(a)(2)(B).

DISPOSITION: The article of drug was reconditioned. Costs of supervision and court costs and fees were paid and bond released. (F.D.C. No. 67250; S. No. 98-716-198; S.J. No. 3)

Medical Devices

PRODUCT: Excimer Laser System, at Orlando, Fla. (M.D. Fla.); Civil Action No. 97-982-CIV-ORL-19.

CHARGED 8-8-97: The article of device, in possession of Dr. Albert Neumann at the Neumann Eye Institute, Inc., in Orlando, Fla., was adulterated because it was a Class III device under 21 U.S.C. Section 360c(f)(1), which was required to have in effect either an approved application for premarket approval (PMA) under 21 U.S.C. Section 360e, or an approved investigational device exemption (IDE) under 21 U.S.C. Section 360j(g), and no such PMA or IDE was in effect--501(f)(1)(B).

DISPOSITION: The article was destroyed. (F.D.C. No. 67192; S. No. 97-711-978; S.J. No. 4)

PRODUCT: One Excimer Laser System, at Atlanta, Ga. (N.D. Ga.); Civil Action No. 1:97-CV-1811-JOF.

CHARGED 6-24-97: The article of device, in the possession of Woodhams Eye Clinic, in Atlanta, Ga., was adulterated because it was a Class III device under 21 U.S.C. Section 360c(f)(1), and there was no approved application for premarket approval in effect pursuant to 21 U.S.C. Section 360e and no investigational device exemption was in effect pursuant to 21 U.S.C. Section 360j(g)--501(f)(1)(B).

DISPOSITION: The article was destroyed. (F.D.C. No. 67193; S. No. 96-720-783; S.J. No. 5)

Drugs/Veterinary Use

PRODUCT: Animal Drugs, at Redmond, Wash. (W.D. Wash.); Civil Action No. C94-1120C.

CHARGED 7-29-94: While held for sale after shipment of one or more of their components in interstate commerce at Argent Chemical Laboratories, Inc., in Redmond, Wash., 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 or, upon inspection, failed to conform to, and were not operated and administered in conformity with current good manufacturing practice--501(a)(2)(B). …

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