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  6. Warning Letters 2017
  1. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

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.     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

University of California Los Angeles (UCLA)

Gallium 68 (68GA-PSMA) (Prostate Cancer Imaging webpage and brochure)

12/28/2017

AVANTHI, INC.

ANDA 203495 LOMAIRA (phentermine hydrochloride USP) tablets, CIV

12/19/2017

Amherst Pharmaceuticals, LLC and Magna Pharmaceuticals, Inc. 

NDA 022196 Zolpimist (zolpidem tartrate) Oral Spray (C-IV)

11/14/2017

Cipher Pharmaceuticals, Inc.

NDA 022370 CONZIP (tramadol hydrochloride) extended-release capsules for oral use, CIV

8/24/2017

Orexigen Therapeutics, Inc.


 

NDA 200063 CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release Tablets

5/18/2017

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Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

Imprimis Pharmaceuticals Inc.

False and misleading claims

12/21/2017

Aphena Pharma Solutions - Tennessee, LLC 

Fenofibrate 48mg, NDC 43353-248, and Montelukast Sodium, NDC 43353-252;  failure to comply with drug listing requirements

12/5/2017

A-S Medication Solutions LLC.

failure to comply with drug listing requirements

6/5/2017

Prestige Brands Holdings, Inc.

failure to comply with drug listing requirements

6/1/2017

 Exact-Rx, Inc.

 Exact-Rx Sodium Sulfacetamide and Sulfer 10%/5% Cleanser, NDC 42808-112 listing is inaccurate

 4/19/2017

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Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

Schrofner Cosmetics Gmbh

CGMP/Finished Pharmaceuticals/Adulterated

12/20/2017

Delta Laboratories Pty. Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

12/19/2017

Fresenius Kabi Oncology Limited (Baddi)

CGMP/Finished Pharmaceuticals/Adulterated

12/18/2017

Wuhan Chinese Moxibustion Technology Dev. Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

12/18/2017

Prosana Distribuciones S.A. de C.V.

CGMP/Finished Pharmaceuticals/Adulterated

12/18/2017

Deserving Health International Corp.

CGMP/Finished Pharmaceuticals/Adulterated

12/18/2017

AN Co. Ltd

CGMP/Finished Pharmaceuticals/Adulterated

12/13/2017

Amaros Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

12/13/2017

Shanwei Honghui Daily Appliance Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

12/5/2017

Seindni Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

12/5/2017

Fresenius Kabi AG

CGMP/APIs/Adulterated 

12/4/2017

BBCOS srl

CGMP/Finished Pharmaceuticals/Adulterated

11/29/2017

Dae Young Foods Company, Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

11/20/2017

Hangzhou Facecare Cosmetics Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

11/17/2017

Bayer Pharma AG

CGMP/Finished Pharmaceuticals/Adulterated

11/14/2017

Hubei Danjiangkou Danao Pharmaceutical Co., Ltd.

CGMP/APIs/Adulterated 

11/6/2017

Lupin Limited

CGMP/Finished Pharmaceuticals/Adulterated

11/6/2017

Guangzhou Baiyunshan Pharmaceutical Holdings Co. LTD

CGMP/Finished Pharmaceuticals/Adulterated

11/1/2017

Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

10/30/2017

Aztex Enterprises Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

10/20/2017

Kim Chemicals Private Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

10/16/2017

Vital Laboratories Private Limited

CGMP/APIs/Adulterated 

10/10/2017

Dasan E&T Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

9/22/2017

Jiangmen Nowadays Daily Goods Co., Ltd

CGMP/Finished Pharmaceuticals/Adulterated

9/12/2017

Shandong Vianor Biotech Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

9/12/2017

Wuxi Medical Instrument Factory

CGMP/Finished Pharmaceuticals/Adulterated

9/7/2017

Firson Co. Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

8/31/2017

Hetero Labs Limited

CGMP/Finished Pharmaceuticals/Adulterated

8/15/17

Bicooya Cosmetics Limited

CGMP/Finished Pharmaceuticals/Adulterated

8/11/2017

Homeolab USA Inc.

CGMP/Finished Pharmaceuticals/Adulterated

8/2/2017

Cellex-C International Inc.

CGMP/Finished Pharmaceuticals/Adulterated

8/2/2017

Foshan Flying Medical Products Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

8/1/2017

Skin Sciences Laboratory, Inc.

CGMP/Finished Pharmaceuticals/Adulterated

7/28/2017

Tubilux Pharma S.p.A.

CGMP/Finished Pharmaceuticals/Adulterated

7/6/2017

Vista Pharmaceuticals Limited

CGMP/Finished Pharmaceuticals/Adulterated

7/5/2017

Shandong Analysis and Test Center

CGMP/APIs/Adulterated 

6/22/2017 

Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory

CGMP/APIs/Adulterated

5/11/2017

Vikshara Trading & Investments Ltd

CGMP/Finished Pharmaceuticals/Adulterated

4/28/2017

China Resources Zizhu Pharmaceutical Co., Ltd.

CGMP/APIs/Adulterated

4/24/2017

Sal Pharma

CGMP/APIs/Adulterated

4/20/2017

Divi’s Laboratories Ltd. (Unit II)

CGMP/APIs/Adulterated

4/13/2017

Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd.

CGMP/APIs/Adulterated

4/5/2017

Mylan Pharmaceuticals, Inc.

CGMP/Finished Pharmaceuticals/Adulterated

4/3/2017

Indoco Remedies Limited

CGMP/Finished Pharmaceuticals/Adulterated

3/27/2017

Opto-Pharm Pte Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

3/16/2017

USV Private Limited

CGMP/Finished Pharmaceuticals/Adulterated

3/10/2017

Badrivishal Chemicals & Pharmaceuticals

CGMP/APIs/Adulterated

3/2/2017

Lumis Global Pharmaceuticals Co. Ltd.

CGMP/APIs/Adulterated

3/2/2017

Jinan Jinda Pharmaceutical Chemistry Co., Ltd.

CGMP/APIs/Adulterated

2/24/2017

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

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Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

Sohail M. Khan, M.D.   

Clinical Investigator

10/10/2017

Laveeza Bhatti, M.D., Ph.D.

Clinical Investigator

8/4/2017

Vertical Pharmaceuticals, Inc.

PADE

5/10/2017

Adolfo E. Kaplan, M.D.

Clinical Investigator

4/20/2017

Targeted Medical Pharma​, Inc.

Sponsor

3/29/2017

Merrill D. Benson, M.D.

Clinical Investigator

​3/20/2017

Cassandra E. Curtis, M.D.

Clinical Investigator

1/27/2017

Kang Zhang, M.D., Ph.D

Sponsor-Investigator

1/5/2017

STI Pharma LLC

PADE

11/21/2016

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Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

Investra-24hs

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

12/28/2017

Worldwide Drug Store

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

9/19/2017

Rx Partners

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

9/19/2017

Pharmempire

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

9/19/2017

PharmCash

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

9/19/2017

MyRxCash

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

9/19/2017

MediPK

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

9/19/2017

Medicina Mexico

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

9/19/2017

HA Stores, Ltd

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

9/19/2017

GlavMed

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

9/19/2017

CanAmerica Global

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

9/19/2017

Bulk2 USA

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

9/19/2017

American Pharmacy Group

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

9/19/2017

247Med

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

9/19/2017

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