Drugs

Warning Letters 2018

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.     FDA Warning Letters

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 Freedom of Information Page.

Office of Prescription Drug Promotion

Company/Individual

Product/Issue

Issue Date

 Collegium Pharmaceuticals, Inc.

 

 NDA 208090 Xtampza ER (oxycodone) extended-release capsules, for oral use

 2/9/2018

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Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

 

 

 

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Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

McCallum Manufacturing Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

4/9/2018

Luen Wah (HK) Medicine Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

4/6/2018

It’S Hanbul Co., Ltd.; dba Hanbul Cosmetics Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

3/29/2018

Keshava Organics Pvt. Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

3/15/2018

Labocont Industrial SRL

CGMP/Finished Pharmaceuticals/Adulterated

3/9/2018

Malladi Drugs & Pharmaceuticals Limited

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

3/9/2018

Quali-Controle & Quali-Controle C.E.BAC

CGMP/Finished Pharmaceuticals/Adulterated

3/5/2018

Nan San (HK) Pharmaceutical Factory Limited

CGMP/Finished Pharmaceuticals/Adulterated

2/23/2018

Zhejiang Ludao Technology Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

2/23/2018

Alchymars ICM SM Private Limited

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

2/16/2018

Nowcos Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

2/14/2018

Casmara Cosmetics, S.A.

CGMP/Finished Pharmaceuticals/Adulterated

2/12/2018

Shanghai Weierya Daily Chemicals Factory

CGMP/Finished Pharmaceuticals/Adulterated

2/7/2018

Cosmecca Korea Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

2/2/2018

Celltrion, Inc.

CGMP/Finished Pharmaceuticals/Adulterated

1/26/2018

Polaroisin International Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

1/25/2018

Daito Kasei Kogyo Co., LTD., Okayama Factory

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

1/18/2018

Wong Lap Kwong Medicine Company Limited

CGMP/Finished Pharmaceuticals/Adulterated

1/11/2018

Hunan Norchem Pharmaceutical Co. Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

1/9/2018

Yicheng Chemical Corporation

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

1/2/2018

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Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

Sohail M. Khan, M.D.

Clinical Investigator

10/10/2017

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Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

King Bio, Inc.

Unlawful Sale of Unapproved and Misbranded Drug Products to United States Consumers over the Internet

1/11/2018

GUNA, Inc.

Unlawful Sale of Unapproved and Misbranded Drug Products to United States Consumers over the Internet

1/11/2018

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Page Last Updated: 04/19/2018
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