Drugs

Warning Letters 2014

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/IssueIssue Date

 

Sunovion Pharmaceuticals, Inc. 
 

NDA 022416 Aptiom (eslicarbazepine acetate) Tablets

12/15/2014

Sciecure Pharma, Inc.

NDA 018708 DORAL (quazepam) Tablets for oral use C-IV

10/29/2014

Pacira Pharmaceuticals, Inc.

NDA 022496 EXPAREL (bupivacaine liposome injectable suspension)

9/23/2014

Cipher Pharmaceuticals, Inc.

NDA 021612 Lipofen (fenofibrate capsules, USP) for oral use

9/11/2014

OptumInsight Life Sciences, Inc. (US Agent for Concordia Pharmaceuticals, Inc.)

NDA 022331 Kapvay (clonidine hydrochloride) extended-release tablets

7/7/2014

Gilead Sciences, Inc.

NDA 21356, 22577 Viread (tenofovir disoproxil fumarate) Tablets and Powder, for oral use

6/27/2014

Citius Pharmaceuticals, LLC

NDA 202088 Suprenza (phentermine hydrochloride) orally disintegrating tablet, CIV

6/9/2014

Alvogen, Inc.

ANDA 091681 Disulfiram Tablets, USP

5/6/2014

Institut Biochimique SA (IBSA)

NDA 021924 Tirosint (levothyroxine sodium) capsules, for oral use

2/24/2014

Mission Pharmaceutical Company

NDA 021618 Tindamax (tinidazole) tablets for oral use

1/24/2014

Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

Andapharm, LLC
(WARNING LETTER)

 

GDUFA: failure to pay fees

8/26/2014

Marck Biosciences Limited
(WARNING LETTER)

GDUFA: failure to pay fees

8/26/2014

Orgsyn Laboratory Inc.
(WARNING LETTER)

GDUFA: failure to pay fees

8/26/2014

Microtest Laboratories, Inc.
(WARNING LETTER)

GDUFA: failure to pay fees

8/26/2014

Korea United Pharm Inc.
(WARNING LETTER)

GDUFA: failure to pay fees

8/7/2014

Colgate Oral Pharmaceuticals Inc.
(WARNING LETTER)

GDUFA: failure to pay fees

8/7/2014

Explora Laboratories SA
(WARNING LETTER)

GDUFA: failure to pay fees

8/7/2014

Calaire Chimie SAS

(WARNING LETTER

GDUFA: failure to pay fees

7/18/2014

Contract Coating Inc.
(Warning Letter)

failed to pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012

7/18/2014

American Antibiotics, Inc.

(Warning Letter)

failed to self-identify the facility and pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012 

6/2/2014

Antibioticos, S.A.
(Warning Letter)

failed to self-identify the facility and pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012

6/2/2014

Office of Manufacturing and Product Quality

Company/Individual

Product/Issue

Issue Date

Hikma Pharmaceuticals Limited
(WARNING LETTER)

 

regulations for finished pharmaceuticals

10/21/2014

Sharp Global Limited
(WARNING LETTER)

 

manufacture of active pharmaceutical ingredients (APIs)

10/15/2014

Beijing Shunxin Meihua Bio-technical Co., Ltd.
(WARNING LETTER)

firm limited and/or refused an FDA inspection

9/29/2014

Hospira Australia Pty, Limited
(WARNING LETTER)

 

regulations for finished pharmaceuticals

9/26/2014

China Resources Sanjiu Medical and Pharmaceutical Co., Ltd.
(WARNING LETTER)

regulations for finished pharmaceuticals

9/19/2014

Zhejiang Jiuzhou Pharmaceutical Co., Ltd.
(WARNING LETTER)

manufacture of active pharmaceutical ingredients (APIs)

7/9/2014

Marck Biosciences Limited
(WARNING LETTER)

regulations for finished pharmaceuticals

7/8/2014

Trifarma S.p.A.
(WARNING LETTER)

manufacture of active pharmaceutical ingredients (APIs)

7/7/2014

Apotex Pharmachem India Pvt Ltd.
(Warning Letter)

manufacture of active pharmaceutical ingredients (APIs)

6/16/2014

Tianjin Zhongan Pharmaceutical Co., Ltd.
(Warning Letter)

manufacture of active pharmaceutical ingredients (APIs) 

6/10/2014 

Sun Pharmaceutical Industries Limited
(WARNING LETTER)

regulations for finished pharmaceuticals

5/7/2014

SANUM-Kehlbeck GmbH & Co. KG
(WARNING LETTER)

regulations for finished pharmaceuticals

4/11/2014

SmithKline Beecham (Cork) Ltd.
(WARNING LETTER)

manufacture of active pharmaceutical ingredients (APIs)

3/18/2014

Smruthi Organics Ltd
(WARNING LETTER)

manufacture of active pharmaceutical ingredients (APIs)

3/6/2014

Canton Laboratories Private Limited
(WARNING LETTER)

manufacture of active pharmaceutical ingredients (APIs)

2/27/2014

USV Limited
(WARNING LETTER)

regulations for finished pharmaceuticals

2/6/2014

CBSCHEM Limited
(WARNING LETTER)

labeling/relabeling of active pharmaceutical ingredients (APIs)

1/31/2014

Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

Michele A. Sewell, M.D.
(WARNING LETTER)

Clinical Investigator

4/30/2014

Rogerio A. Lobo, M.D.
(WARNING LETTER)

Clinical Investigator

4/18/2014

AMKS Time Release Laboratories, LLC
(WARNING LETTER)

Sponsor Investigation

4/10/2014

Colorado Histo-Prep
(WARNING LETTER)

Bioresearch Monitoring

3/11/2014

Ralf Zimmerman, M.D.
(WARNING LETTER)

Clinical Investigator

2/21/2014

Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

no letters