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

 

 

 

 

Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

 

 

 

 

Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

Badrivishal Chemicals & Pharmaceuticals

CGMP/APIs/Adulterated

3/2/2017

Lumis Global Pharmaceuticals Co. Ltd.

CGMP/APIs/Adulterated

3/2/2017

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

 Kang Zhang, M.D., Ph.D.

 Sponsor-Investigator

 1/5/17

 

Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

 

 

 

Back to Top

Page Last Updated: 03/17/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English