Drugs

Warning Letters 2017

These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications) and CDER Headquarters Warning Letters.

For District Office Warning Letters see the Main FDA FOI Warning Letters Page.  Some of the letters have been redacted or edited to remove confidential information. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.  If you wish to obtain available additional information on the current status of an issue in a particular warning letter or notice of violation on this website, please contact the Agency or the recipient of the letter directly.  Inquiries to FDA should be sent to: 

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857

Instructions for how to submit an FOI request can be found on the FDA FOI Page.

Office of Prescription Drug Promotion

Company/Individual

Product/Issue

Issue Date

Orexigen Therapeutics, Inc.


 

NDA 200063 CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release Tablets

5/18/2017

 

Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

A-S Medication Solutions LLC.

failure to comply with drug listing requirements

6/5/2017

Prestige Brands Holdings, Inc.

failure to comply with drug listing requirements

6/1/2017

 Exact-Rx, Inc.

 Exact-Rx Sodium Sulfacetamide and Sulfer 10%/5% Cleanser, NDC 42808-112 listing is inaccurate

 4/19/2017

 

Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory

CGMP/APIs/Adulterated

5/11/2017

Vikshara Trading & Investments Ltd

CGMP/Finished Pharmaceuticals/Adulterated

4/28/2017

Sal Pharma

CGMP/APIs/Adulterated

4/20/2017

Divi’s Laboratories Ltd. (Unit II)

CGMP/APIs/Adulterated

4/13/2017

Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd.

CGMP/APIs/Adulterated

4/5/2017

Mylan Pharmaceuticals, Inc.

CGMP/Finished Pharmaceuticals/Adulterated

4/3/2017

Indoco Remedies Limited

CGMP/Finished Pharmaceuticals/Adulterated

3/27/2017

Opto-Pharm Pte Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

3/16/2017

USV Private Limited

CGMP/Finished Pharmaceuticals/Adulterated

3/10/2017

Badrivishal Chemicals & Pharmaceuticals

CGMP/APIs/Adulterated

3/2/2017

Lumis Global Pharmaceuticals Co. Ltd.

CGMP/APIs/Adulterated

3/2/2017

Jinan Jinda Pharmaceutical Chemistry Co., Ltd.

CGMP/APIs/Adulterated

2/24/2017

Megafine Pharma (P) Ltd.

CGMP/APIs/Adulterated

2/24/2017

Chongqing Pharma Research Institute Co., Ltd.

CGMP/APIs/Adulterated

2/14/2017

Resonance Laboratories Pvt. Ltd.

CGMP/APIs/Adulterated

2/3/2017

Sato Pharmaceutical Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

2/2/2017

Ausmetics Daily Chemicals (Guangzhou) Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

1/31/2017

Zhejiang Bangli Medical Products Co., Ltd

CGMP/Finished Pharmaceuticals/Adulterated

1/26/2017

CTX Life Sciences Pvt., Ltd.

CGMP/APIs/Adulterated

1/18/2017

Porton Biopharma, Limited

CGMP/APIs/Adulterated

1/17/2017

FACTA Farmaceutici S.p.A

CGMP/Finished Pharmaceuticals/Adulterated

1/13/2017

Ningbo Zhixin Bird Clean-Care Product Company, Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

1/6/2017

Suzhou Pharmaceutical Technology Co., Ltd

CGMP/APIs/Adulterated

1/6/2017

Sato Yakuhin Kogyo Co., Ltd.
 

CGMP/Finished Pharmaceuticals/Adulterated

1/6/2017

 

Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

Vertical Pharmaceuticals, Inc.

PADE

5/10/2017

Targeted Medical Pharma​, Inc.

​Sponsor

3/29/2017

Merrill D. Benson, M.D.

Clinical Investigator

​3/20/2017

Cassandra E. Curtis, M.D.

Clinical Investigator

1/27/2017

Kang Zhang, M.D., Ph.D

Sponsor-Investigator

1/5/2017

STI Pharma LLC

PADE

11/21/2016

 

Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

 

 

 

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Page Last Updated: 06/16/2017
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