IA #66-40 - 6/20/88, "Automatic Detention of Drugs From Firms That Have Not Met
Drug GMP's -- Attach 3/26/04
Alert #66-40 replaces alerts numbered 56-03, 56-04, 56-05 and 65-01.
TYPE OF ALERT: AUTOMATIC DETENTION
PRODUCT: Various drugs (See attachment)
PROBLEM: Failure to Meet Drug GMP's
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 the methods and controls used in its
manufacture and control of pharmaceutical products do not
appear to conform to current good manufacturing practices
within the meaning of Section 501(a)(2)(B)."
RECOMMENDING
OFFICE: Center For Drug Evaluation and Research, Office of Compliance
(HFD-300)
REASON FOR
ALERT: Foreign inspections of pharmaceutical manufacturers are being
performed. FDA will detain affected products 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 corrections have been made, the respective
firm's pharmaceutical products will be removed from automatic
detention.
INSTRUCTIONS: Automatically detain the specified pharmaceutical products
from the firms listed in the attachment to this alert.
IA# 66-40 Attachment, Revised 3/26/04
LIST OF FIRMS AND PHARMACEUTICALS TO BE AUTOMATICALLY DETAINED
Firm Pharmaceuticals
ANSA Bulk Antibiotics
Ismit, Turkey
Firm: Bavarian Red Cross Products: All Products (including
Herzog-Heinrich-Strasse 4 Whole Blood, Red Blood Cells and
D080336, Munich, Germany Whole Blood CPDA-1, and
US License #1002-001 Recovered Plasma)
Product Code: "BI"
12/29/98
Note: Bavarian Red Cross Operations at the following locations under their U.S.
license #1002.
Addresses: Firm Bavarian Red Cross
Herzog-Heinrich-Strasse 4
D-80336 Munich, Germany
US License #1002-001
FEI# 30025457631
Hoher Kreuz Weg 7
D-93055 Regensburg, Germany
US License #1002-002
FEI# 3002545773
Westheimer Strasse 80
D-86156 Augsburg, Germany
US License #1002-003
FEI# 3002545774
Flurstrasse 17
D-90419 Nuremburg, Germany
US License #1004-004
FEI# 3002545776
Klinikstrasse 5
D-97070 Wurzburg, Germany
US License #1002-005
FEI #3002545780
D-95445 Bayreuth, Germany
US License #1002-006
FEI #3002545781
Biologische Heilmittel Heel GmbH** All Injectable Drug**
Ruhrstrasse 14, Postfach 729 Products
Baden-Baden, Germany 4/26/95
FEI #1000202309
Revised text instructions
5/5/03
**All drug products claimed or purported to be sterile, and all drug products,
which by virtue of their intended use should be sterile, i.e. ophthalmic
products. Other homeopathic drug products imported from the subject firm and
labeled "Not for Injection", or "For Oral Use", are not recommended for DWPE.
IA# 66-40 Attachment, Revised 3/26/05 PAGE 2
LIST OF FIRMS AND PHARMACEUTICALS TO BE AUTOMATICALLY DETAINED
Compagnie Oris Industries Selenomethionine 75
Laboratory of Biomedical Imaging Injection
(aka LAPIB)
Gif-sur-Yvette, Saclay, France
Dysers S.A.L. Non-Sterile
Depositos 12 bulk drug product
40004 Segovia, Spain (5/1/92)
Guangdong Pharmaceutical Active Pharmaceutical Ingredients
Factory 61H[][]; 61G[][]
91 Fangcum Dadao 12/12/97
Guangzhow, Guangdong PR
China (Mainland)
FEI #1548
Hampshire Chemicals, Ltd. All bulk pharmaceuticals
Seal Sands Road 66[][]S[][]
Middlesborough, Cleveland, TS2 1UD, 1/26/96
United Kingdom
MID# GBHAMCHECLE
FEI# 1000408698
Ningxia Pharmaceutical Factory Tetracycline/53E[]S80
Ningxia Branch 2/13/02
Ningxia, China
FEI# 3000224186
Shanghai 15 Factory Metformin HCL/ 61PCS55
Shanghai Medicinal Ltd. Clozapine / 65VCS13
1440 Beiyao Street 2/12/04
Shanghai, China
FEI# 3002808230
Societe Chimique Grevis Sterile Bulk Pharmaceutical
Avenue de la Paix Chemicals
Limay, France
Topchem, S.R.L. All bulk drugs
Viale Andrea Doria 17 (8/4/92)
Milan, Italy 20124