IA #66-40 - 6/20/88, IMPORT ALERT #66-40 "Detention Without Physical
Examination of Drugs From Firms Which Have Not Met Drug GMPs"
(Revised, August 17, 2007) -- Attach 3/16/09
Alert #66-40 replaces alerts numbered 56-03, 56-04, 56-05 and 65-01.
*** The revision of this import alert dated 8/17/2007 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 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: *** Districts may detain *** the specified pharmaceutical
Products from the firms listed in the attachment to this
alert.
IA# 66-40 Attachment, Revised 1/21/09
LIST OF FIRMS AND PHARMACEUTICALS *** SUBJECT TO DETENTION WITHOUT PHYSICAL
EXAMINATION ***
Firm Pharmaceuticals
ANSA Bulk Antibiotics
Ismit, Turkey
Firm: Bavarian Red Cross Products: All Products (including
Herzog-Heinrich-Strasse 4 Whole Blood, Red Blood Cells
D080336, Munich, Germany and 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
IA# 66-40 Attachment, Revised 1/21/09 PAGE 2
LIST OF FIRMS AND PHARMACEUTICALS *** SUBJECT TO DETENTION WITHOUT PHYSICAL
EXAMINATION ***
** 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.
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
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
Kunshan Chemicals & Pharmaceutical Co., All Products
No 242 Kun Tai Road GPI=DR
Kunshan City 8/30/07
Jiangsu
China
FEI# 3002931612
IA# 66-40 Attachment, Revised 1/21/09 PAGE 3
LIST OF FIRMS AND PHARMACEUTICALS *** SUBJECT TO DETENTION WITHOUT PHYSICAL
EXAMINATION ***
Northeast General Pharmaceutical Factory All pharmaceutical products
No. 37 Zhinggong Bei Street GPI - DR
Tiexi District 10/30/07
Shenyang, Liaoning
China
FEI# 3002807700
Changzhou SPL Company, Ltd. All heparin products
3 Changhong West Rd. 57D--38
Hutang Township 61L--22
Jiangsu 61L--30
China 61L--08
FEI# 3003335664 74L--IS*
80N--ZW*
81J--OX*
81K--FF*
81J--BR*
88I--AZ*
3/10/08
*Medical Device product codes are included to prevent potential miscoding of
products. To FDA's knowledge, Changzhou SPL Company does not manufacture
medical devices.
Ranbaxy Laboratories Ltd. All finished pharmaceutical
Industrial Area No. 3, products and APIs,
Dewas, India GPI=DR GPI=AB
FEI# 3002807977 9/16/08
Note: This firm is the sole source of Ganciclovir API (62V[][]27). Districts
should contact DIOP at 301-443-6553, if entries of Ganciclovir API or finished
dosage forms are offered for import.
Ranbaxy Laboratories All finished pharmaceutical
Limited, Paonta Sahib, products and APIs,
Himachal Pradesh, India GPI=DR GPI=AB
FEI# 3002807978 9/16/08
Note: This firm is the sole source of Ganciclovir API (62V[][]27). Districts
should contact DIOP at 301-443-6553, if entries of Ganciclovir API or finished
dosage forms are offered for import.
IA# 66-40 Attachment, Revised 3/16/09 PAGE 4
LIST OF FIRMS AND PHARMACEUTICALS *** SUBJECT TO DETENTION WITHOUT PHYSICAL
EXAMINATION ***
Shangahi No. 1 Biochemical & All heparin products
Pharmaceutical Co., Ltd. 55R[][]75
387 Shangqui Road 55R[][]99
Shanghai 57D[][]38
China 61L[][]22
FEI# 3002664189 61L[][]30
61L[][]08
74L[][]IS
80N[][]ZW
81J[][]OX
81K[][]FF
81J[][]BR
88I[][]AZ
1/21/09
Shanghai No.1 Biochemical & All heparin products
Pharmaceutical Co., Ltd.
Minhang Branch (SBPC, Minhang) 55R[][]75
1317 Jianchuan Road, Minhang District 55R[][]99
Shanghai, China 57D[][]38
FEI# 3004475606 61L[][]22
61L[][]30
61L[][]08
74L[][]IS
80N[][]ZW
81J[][]OX
81K[][]FF
81J[][]BR
88I[][]AZ
1/21/09
Shanghai No. 1 Biochemical & All heparin products
Pharmaceutical Co., Ltd. 55R[][]75
Room A-403, 494 Zhongxing Rd. 55R[][]99
Shanghai 57D[][]38
China 61L[][]22
FEI# 3005944228 61L[][]30
61L[][]08
74L[][]IS
80N[][]ZW
81J[][]OX
81K[][]FF
81J[][]BR
88I[][]AZ
1/21/09
Chongqing Imperial Bio-Chem Co. Ltd. All APIs
5 Yanghe Sancun, GPI=DR
19-7 Citic Bank Bldg, GPI=AB
Jiangbei Dist. Chongqing, 400020 3/16/09
China
FEI# 3004074796
Chongqing Paiquiang Agribyproduct Co., Ltd All APIs
158 Gonglongqing Chongqing, GPI=DR
China GPI=AB
FEI# 3007458872 3/16/09
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