FDA 2015- WARNING LETTER AND ISSUE Office of Manufacturing Quality - Pharma Jobs- PJ

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Sunday 24 January 2016

Home AUDIT RELATED ISSUE FDA 2015- WARNING LETTER AND ISSUE Office of Manufacturing Quality

FDA 2015- WARNING LETTER AND ISSUE Office of Manufacturing Quality

FDA 2015- WARNING LETTER AND ISSUE
Office of Manufacturing Quality


Company/CC
Product/Issue
Issue Date
Zhejiang Hisun Pharmaceutical Co., Ltd.
(WARNING LETTER)
CGMP/Active Pharmaceutical Ingredients (APIs)
12/31/2015
Cadila Healthcare Limited
(WARNING LETTER)
CGMP/Active Pharmaceutical Ingredients (APIs)
12/23/2015
Sun Pharmaceuticals Industries Ltd.
(WARNING LETTER)
CGMP/Finished Pharmaceuticals/Adulterated
12/17/2015
Chan Yat Hing Medicine Factory
(WARNING LETTER)
CGMP/Finished Pharmaceuticals/Adulterated
12/15/2015
Dr. Reddy's Laboratories Limited
(WARNING LETTER)
CGMP/Active Pharmaceutical Ingredients (APIs)
11/5/2015
Sandoz Private Limited
(WARNING LETTER)
CGMP/Finished Pharmaceuticals/Adulterated
10/22/2015
Unimark Remedies Ltd.
(WARNING LETTER)
CGMP/Active Pharmaceutical Ingredients (APIs)
9/28/2015
Jaychem Industries, Inc.
(WARNING LETTER)
CGMP/Finished Pharmaceuticals/Adulterated
9/4/2015
Pan Drugs Limited
(WARNING LETTER)
CGMP/Active Pharmaceutical Ingredients (APIs)
9/2/2015
Mylan Laboratories Limited
(WARNING LETTER)
CGMP/Finished Pharmaceuticals/Adulterated
8/6/2015
Sipra Labs Limited
(WARNING LETTER)
regulations for testing finished pharmaceuticals and active pharmaceutical ingredients (APIs)
7/23/2015
Mahendra Chemicals 
(WARNING LETTER)
CGMP/Active Pharmaceutical Ingredients (APIs) 
 7/13/2015
Attix Pharmaceuticals
(WARNING LETTER)
 
CGMP/Finished Pharmaceuticals/Adulterated
6/22/2015
VUAB Pharma a.s. 
(WARNING LETTER)
CGMP/Finished Pharmaceuticals/Adulterated 320-15-10
5/27/15 
Yunnan Hande Bio-Tech. Co. Ltd. 
(WARNING LETTER)
 
manufacture of active pharmaceutical ingredients (APIs)
4/6/2015
Hospira S.p.A.
(WARNING LETTER)
regulations for finished pharmaceuticals
3/31/2015
Novacyl (Thailand) Ltd.
(WARNING LETTER)
manufacture of active pharmaceutical ingredients (APIs)
2/27/2015
Cadila Pharmaceuticals Limited
(WARNING LETTER)
manufacture of active pharmaceutical ingredients (APIs)
2/25/2015
Micro Labs Limited
(WARNING LETTER)
regulations for finished pharmaceuticals
1/9/2015
Apotex Research Private Limited
(WARNING LETTER)
 
regulations for finished pharmaceuticals
1/30/2015


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