Drugs

Warning Letters 2016

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

Chiasma, Inc.

Octreotide capsules

12/21/2016

Zydus Discovery DMCC

Saroglitazar Tablets

12/21/2016

Spiraso, LLC

NDA 206323 TUXARIN ER (Codeine phosphate and chlorpheniramine maleate) extended release tablets, CIII

12/13/2016

United-Guardian, Inc.

NDA 19481 RENACIDIN (citric acid, glucono delta-lactone, and magnesium carbonate) Irrigation Solution

12/13/2016

Sanofi-aventis US

NDA 206538 TOUJEO (insulin glargine injection) U-300, for subcutaneous use

12/12/2016

Celgene Corporation

NDA 205437 OTEZLA (apremilast) tablets, for oral use

12/12/2016

Supernus Pharmaceuticals, Inc.

NDA 202810 Oxtellar XR (oxcarbazepine) extended-release tablet, for oral use

10/31/2016

DURECT Corporation AND

Pain Therapeutics, Inc.

NDA 022324 Remoxy (oxycodone) Extended-Release Capsules MA5

PTI-821 (oxycodone) Controlled-Release Capsules MA3

9/8/2016

Celator Pharmaceuticals Inc.

CPX-351 (Cytrabine; Daunorubicin) Liposome Injection

8/25/2016

Shionogi Inc.

NDA 022129 ULESFIA (benzyl alcohol) lotion, for topical use

  

3/29/2016

Hospira, Inc., a Pfizer Company

NDA 021038 Precedex (dexmedetomidine hydrochloride) Injection

1/14/2016

 

Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

Physician Therapeutics LLC
(WARNING LETTER)

Registration and drug listing

10/6/2016

Wallace Cameron International Ltd.
(WARNING LETTER)

Registration and drug listing

9/29/2016

 National Institutes of Health, Clinical Center Pharmacy Department
(Untitled Letter)

 Adulteration

 7/29/2016

 

Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

Wockhardt Limited
(WARNING LETTER)

CGMP/APIs/Adulterated

12/23/2016

Natura Bisse International S.A.
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

12/16/2016

Intega Skin Sciences, Inc.
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

12/15/2016

Antibioticos do Brasil Ltda
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

12/8/2016

Baoying County Fukang Medical Appliance Co., Ltd.
(WARNING LETTER)

limited and/or refused an FDA inspection

12/8/2016

Interquim, S.A.
(WARNING LETTER)

CGMP/APIs/Adulterated

11/22/2016

CP Pharmaceuticals
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

11/16/2016

Dongying Tiandong Pharmaceutical Co., Ltd.
(WARNING LETTER)

CGMP/APIs/Adulterated

11/10/2016

Srikem Laboratories Pvt. Ltd.
(WARNING LETTER)

CGMP/APIs/Adulterated

11/8/2016

Sekisui Medical Co., Ltd.
(WARNING LETTER)

CGMP/APIs/Adulterated

11/8/2016

Beijing Taiyang Pharmaceutical Industry Co., Ltd.
(WARNING LETTER)

Adulterated/firm limited and/or refused an FDA inspection

10/19/2016

Interpharm Praha A.S.
(WARNING LETTER)

 

CGMP/Finished Pharmaceuticals/APIs/Adulterated

10/18/2016

Teva Pharmaceutical Works Private Limited Company
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

10/13/2016

Laboratoire Sintyl S.A.
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

9/29/2016

Delarange Cosmetics & Healthcare BV
(WARNING LETTER)

 

CGMP/Finished Pharmaceuticals/Adulterated

9/29/2016

Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.
(WARNING LETTER)

 

CGMP/Finished Pharmaceuticals/Adulterated

9/26/2016

Nippon Fine Chemical Co., Ltd
(WARNING LETTER)

refused/limited FDA inspection/adulterated

9/26/2016

Cheng Fong Chemical Co. Ltd.
(WARNING LETTER)

 

CGMP/APIs/Adulterated

9/15/2016

Mappel Industria de Embalagens, SA
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

9/12/2016

Hebei Yuxing Bio-Engineering Co. Ltd.
(WARNING LETTER)

CGMP/APIs/Adulterated

9/6/2016

Lima & Pergher Industria e Comercio S/A
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

8/25/2016

Pan Drugs Limited
(WARNING LETTER)

 

CGMP/Finished Pharmaceuticals/Adulterated

8/25/2016

Xinxiang Tuoxin Biochemical Co. Ltd
(WARNING LETTER)

 

CGMP/APIs/Adulterated

8/19/2016

Unimark Remedies Limited
(WARNING LETTER)

CGMP/APIs/Adulterated

8/12/2016

Zhejiang Hisoar Pharmaceutical Co. Ltd.
(WARNING LETTER)

CGMP/APIs/Adulterated

8/11/2016

Huzhou Aupower Sanitary Commodity Co., Ltd.
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

8/10/2016

Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory
(WARNING LETTER)

CGMP/Active Pharmaceutical Ingredient (API)

8/4/2016

Concept Products Limited
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

7/26/2016

Xiamen Origin Biotech Co., Ltd.
(WARNING LETTER)

 

CGMP/Active Pharmaceutical Ingredient (API)

7/19/2016

SmithKline Beecham Limited
(WARNING LETTER)

CGMP/APIs/Adulterated

6/30/2016

Guangzhou Haishi Biological Technology Co., Ltd.
(WARNING LETTER)

 

CGMP/Finished Pharmaceuticals/Adulterated

6/22/2016

Chongqing Lummy Pharmaceutical Co. Ltd.
(WARNING LETTER
)

CGMP/APIs/Adulterated

6/21/2016

Shanghai Desano Chemical Pharmaceutical Co., Ltd.
(WARNING LETTER)

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

6/16/2016

S.R. Burzynski Manufacturing Facility
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

6/13/2016

Austin Biotechnology Inc.
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

6/2/2016

KO DA Pharmaceutical Co.
(WARNING LETTER)

CGMP/Finished Pharmaceuticals/Adulterated

5/27/2016

Corden Pharma Latina S.p.A.
(WARNING LETTER)

CGMP/Active Pharmaceutical Ingredients (APIs) and finished pharmaceuticals/Adulterated

5/20/2016

Megafine Pharma Limited
(WARNING LETTER)

 

CGMP/Active Pharmaceutical Ingredients (APIs)

5/19/2016

BBT Biotech Gmbh
(WARNING LETTER)

 

CGMP/Active Pharmaceutical Ingredients (APIs)

5/16/2016

Tai Heng Industry Co., Ltd.
(WARNING LETTER)

CGMP/Active Pharmaceutical Ingredients (APIs)

5/12/2016

Polydrug Laboratories Pvt. Ltd.
(WARNING LETTER)

 

CGMP/Active Pharmaceutical Ingredients (APIs)

4/14/2016

Sri Krishna Pharmaceuticals Ltd. - Unit II
(WARNING LETTER)

 

CGMP/Finished Pharmaceuticals/Adulterated

4/1/2016

Emcure Pharmaceuticals Ltd.
(WARNING LETTER)

CGMP/Finished Pharmaceuticals

3/9/2016

Ipca Laboratories Ltd.
(WARNING LETTER)

 

CGMP/Active Pharmaceutical Ingredients (APIs)/Finished Pharmaceuticals/Adulterated

1/29/2016

 

Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

STI Pharma LLC 
(WARNING LETTER)

PADE WL

11/21/2016

Navinta LLC 
(WARNING LETTER)

PADE WL

9/26/2016

Elite Laboratories Inc. 
(WARNING LETTER)

PADE WL

8/25/2016

John D. Gabriel, M.D. 
(WARNING LETTER)

Clinical Investigator

6/28/2016

Jose Giron, M.D.
(WARNING LETTER)

Clinical Investigator

5/19/2016

Semler Research Center Private Limited
(UNTITLED LETTER)

 

Bioequivalence

4/20/2016

Neuralight HD, LLC
(WARNING LETTER)

Sponsor

4/14/2016

Oeyama-Moto Cancer Research Foundation IRB
(WARNING LETTER)

 

Institutional Review Board

4/7/2016

Oeyama-Moto-Medical Group Foundation, LLC
(WARNING LETTER)

 

Sponsor

3/29/2016

Benedict S. Liao, M.D.
(WARNING LETTER)

 

Clinical Investigator

3/29/2016

Cheta Nand, M.D.  
(WARNING LETTER)

Clinical Investigator

3/10/2016

Pikeville Medical Center Inc. IRB
(WARNING LETTER)

 

Institutional Review Board

3/1/2016

Jamaica Hospital Medical Center IRB
(WARNING LETTER)

Institutional Review Board

2/24/2016

Alexander Neumeister, M.D.
(WARNING LETTER)

Clinical Investigator

2/9/2016

 

Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

Global Drug Supply

Shipment of Unapproved New Drugs and Misbranded Drugs to the United States

12/6/2016

Shop Anabolics

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

6/2/2016

Steroid Bazaar

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

6/2/2016

Pharmaceutical Associates, Inc.

Guaifenesin and Codeine Phosphate 100 mg/10 mg per 5 ml (NDC 0121-1775)

3/23/2016

Moore Medical, LLC

Wallcur LLC’s “Practi-0.9% Sodium Chloride”

1/20/2016

PSS World Medical, Inc.

Wallcur LLC’s “Practi-0.9% Sodium Chloride”

1/20/2016

 

Page Last Updated: 03/15/2017
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