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U.S. Department of Health and Human Services

Animal & Veterinary

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CONSENT DECREE ENTERED IN ANIMAL DRUG CGMP CASE -1999

FDA Veterinarian Newsletter January/February 1999 Volume XIV, No I

On October 20, 1998, the U.S District Court for the Central District of California incorporated into an order the entry of a Consent Decree for Permanent Injunction between the United States, Anthony Products Company, doing business as Anpro Pharmaceuticals, and its president, James Viscio. Anthony Products is an animal drug manufacturer that has a long history of violating current good manufacturing practice for finished pharmaceuticals (GMPs; 21 CFR 211) regulations.

Under the Consent Decree, the firm and its president are permanently restrained and enjoined from manufacturing, processing, packaging, labeling, testing, holding, and distributing any drugs at their establishment in El Monte, California until the methods, facilities, and controls used there are in compliance with current GMP regulations. Also, within 90 days of the entry of this decree, Anthony Products must select a person(s) qualified to make inspections of facilities where their drugs are manufactured, processed, packaged, labeled, tested, or held. That person(s) must inspect the defendant's facilities located in Irwindale and Arcadia, CA, and determine whether the facilities are in conformity with GMP requirements. All GMP deviations must be corrected within that 90-day period.

If the defendants fail to comply with these requirements within 90 days, they are required to immediately: 1) recall, at their expense, any drug found to violate the Federal Food, Drug, and Cosmetic Act or the requirements of the Consent Decree, and 2) halt all manufacturing, processing, packaging, labeling, testing, and distribution of all drugs or component parts, unless FDA provides written authorization to resume their operations. Failure to comply with the terms of the decree may also result in civil or criminal penalties.

FDA's Los Angeles District Office conducted the investigation which lead to this Consent Decree. CVM's Division of Compliance, FDA's Office of the Chief Counsel, and the U.S. Department of Justice's Office of Consumer Litigation were in charge of the case processing and approval.