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