IA #68-02 - 3/16/90, "Detention Without Physical Examination of Veterinary
Drugs From Firms That Have Not Met Drug GMPs" (Revised, November 5, 2007) --
Attachment 4/18/07
*** The revision of this import alert dated 11/5/2007 changes the name of
the import alert and removes references to (Automatic Detention).
Changes are bracketed with ***
TYPE OF ALERT: *** Detention Without Physical Examination ***
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 *** may *** 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 *** Detention Without Physical
Examination ***.
INSTRUCTIONS: *** Districts may 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,
ATTACHMENT - IMPORT ALERT #68-02 Revised 4/18/07
LIST OF FIRMS AND PHARMACEUTICALS SUBJECT TO DETENTION WITHOUT PHYSICAL
EXAMINATION.
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
Pucheng Chia Tai All Active Pharmaceuticals
Biochemistry Co., Ltd. Ingredients (APIs)
305 Chai Tai Road
Fujian Province GPI=DR
Pucheng GPI=VD
China 4/18/08
FEI# 3002930463
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
Shaanxi Hanjiang Pharmaceutical Ltd. All Active Pharmaceutical
6, Shian Road, Ingredients
Hanzhong GPI=DR
China 11/5/07
FEI# 3003011617
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