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/IndividualProduct/IssueIssue Date

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

NDA 022331 Kapvay (clonidine hydrochloride) extended-release tablets7/7/2014

Gilead Sciences, Inc.
 

NDA 21356, 22577 Viread (tenofovir disoproxil fumarate) Tablets and Powder, for oral use6/27/2014

Citius Pharmaceuticals, LLC
 

NDA 202088 Suprenza (phentermine hydrochloride) orally disintegrating tablet, CIV6/9/2014

Alvogen, Inc.

ANDA 091681 Disulfiram Tablets, USP5/6/2014

Institut Biochimique SA (IBSA)

NDA 021924 Tirosint (levothyroxine sodium) capsules, for oral use2/24/2014

Mission Pharmaceutical Company

NDA 021618 Tindamax (tinidazole) tablets for oral use1/24/2014

Office of Compliance/Immediate Office 

Company/IndividualProduct/IssueIssue Date
Korea United Pharm Inc.
(WARNING LETTER)
GDUFA: failure to pay fees8/7/2014

Colgate Oral Pharmaceuticals Inc.
(WARNING LETTER)

GDUFA: failure to pay fees8/7/2014
Explora Laboratories SA
(WARNING LETTER)
GDUFA: failure to pay fees8/7/2014
GDUFA: failure to pay fees7/18/2014
Contract Coating Inc.
(Warning Letter)
failed to pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 20127/18/2014

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 20126/2/2014

Office of Drug Security, Integrity and Recalls 

Company/IndividualProduct/IssueIssue Date
   

Office of Manufacturing and Product Quality

Company/Individual

Product/IssueIssue Date
Zhejiang Jiuzhou Pharmaceutical Co., Ltd.
(WARNING LETTER)
manufacture of active pharmaceutical ingredients (APIs)7/9/2014
Marck Biosciences Limited
(WARNING LETTER)
regulations for finished pharmaceuticals7/8/2014
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 pharmaceuticals5/7/2014
SANUM-Kehlbeck GmbH & Co. KG
(WARNING LETTER)
regulations for finished pharmaceuticals4/11/2014
SmithKline Beecham (Cork) Ltd.
(WARNING LETTER)
manufacture of active pharmaceutical ingredients (APIs)3/18/2014
manufacture of active pharmaceutical ingredients (APIs)3/6/2014
manufacture of active pharmaceutical ingredients (APIs)2/27/2014
USV Limited
(WARNING LETTER)
regulations for finished pharmaceuticals2/6/2014
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

 

Page Last Updated: 09/03/2014
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