IA #68-02 - 3/16/90, "Automatic Detention of Veterinary Drugs From Firms That Have Not Met Drug GMPs", Attachment 2/19/04 TYPE OF ALERT: AUTOMATIC DETENTION PRODUCT: Various Veterinary Drugs (See attachment) PRODUCT CODE: Various PROBLEM: Failure to Meet Drug GMP's [DRVG] COUNTRY: Various (See attachment) MANUFACTURER/ SHIPPER: Various (See attachment) CHARGE: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that the methods used in or the facilities or controls used for its manufacturing, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices [Adulteration, Section 501(a)(2)(B)]." RECOMMENDING OFFICE: HFC-131 (Import Operations Branch) REASON FOR ALERT: FDA performs foreign inspections of veterinary pharmaceutical manufacturers. FDA will detain products from inspected firms if inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's). When, and if, FDA confirms that the firm is in compliance with GMP [corrections have been made], the respective firm's pharmaceutical products will be removed from automatic detention. INSTRUCTIONS: Automatically detain the specified veterinary pharmaceutical products from the firms listed in the attachment to this alert. FOI: No purging is required. KEYWORDS: Veterinary, Drugs, GMP's, Automatic Detention ATTACHMENT - IMPORT ALERT #68-02 Revised 2/19/04 LIST OF FIRMS AND PHARMACEUTICALS TO BE AUTOMATICALLY DETAINED FIRM PHARMACEUTICALS Guangdong Pharmaceutical Active Pharmaceutical Ingredients Factory 67B[][]; 67B56 91 Fangcum Dadao 12/12/97 Guangzhow, Guangdond PR, China (Mainland) FEI# 1548 Hoescht AG Bulk Penicillin G Procaine, Bruningstrasse 45 except shipments intended for Postfach 80 03 20 the following NADA sponsor: 6230 Frankfurt AM Main Germany West Agro, Inc. ID# DEHOEAG80FRA 11100 N. Congress Ave. ID# DEHOEAKT8003FRA Kansas City, MO 64153 7/26/94 Sierra Pharmaceuticals Inc. Sterile liquids - 68[]K[][]; S.A de C.V. Small volume parentals 68[][]P[][]; Circuito De Las Misiones Nte. #172 Large volume parentals 68[][]N[][] Mexicali, Mexico 7/24/98 FEI# 3000326613