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

Arog Pharmaceuticals, Inc.

Crenolanib besylate

6/28/2018

Pfizer Inc.

NDA 020472 ESTRING® (estradiol vaginal ring)

6/19/2018

 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

AMI Cosmetic Co., Ltd.

Listing information provided for PureHeals Centella 70 Toning Swab, NDC 59535-0268

6/12/2018

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Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

Apotex Research Private Limited

CGMP/Finished Pharmaceuticals/Adulterated

8/9/2018

Bill Beauty and Health Products Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

8/1/2018

JT Cosmetics & Chemicals Pvt. Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

7/27/2018

Yicheng Goto Pharmaceuticals Co., Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

7/26/2018

Les Produits Chimiques B.G.R., Inc.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

7/24/2018

Yuki Gosei Kogyo Co., Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

7/17/2018

Claris Injectables Limited

CGMP/Finished Pharmaceuticals/Adulterated

7/5/2018

Zhuhai United Laboratories Co., Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

6/27/2018

Foshan Jinxiong Technology Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

6/26/2018

Sichuan Friendly Pharmaceutical Co., Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

6/22/2018

Henan Lihua Pharmaceutical Co. Ltd.    

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

6/12/2018

Biologique Recherche (B.R.) SAS

CGMP/Finished Pharmaceuticals/Adulterated

6/8/2018

Taiwan Biotech Company, Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

5/31/2018

IDT Australia Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

5/23/2018

Kolmar Korea Co. Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

5/18/2018

Jalco Cosmetics Pty. Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

5/18/2018

Europharma Concepts Limited

CGMP/Finished Pharmaceuticals/Adulterated

5/16/2018

Jilin Shulan Synthetic Pharmaceutical Co., Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

5/14/2018

Nox Bellcow Cosmetics Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

5/9/2018

Reine Lifescience

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

5/9/2018

Goran Pharma Private Limited

CGMP/Finished Pharmaceuticals/Adulterated

4/24/2018

Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

4/19/2018

Degasa S.A. De C.V.

CGMP/Finished Pharmaceuticals/Adulterated

4/18/2018

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

 

Paddock Laboratories, LLC

 

failed to comply with the milestone dates in the timetable for completion of a postmarketing requirement (PMR)

6/15/2018

Oeyama-Moto-Medical Group Foundation, LLC

deficiencies with the nonclinical laboratory toxicity studies of an investigational drug conducted at testing facility

5/21/2018

Sohail M. Khan, M.D.

Clinical Investigator

10/10/2017

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Office of Unapproved Drugs and Labeling Compliance

Company/Individual

Product/Issue

Issue Date

Kratom Spot   

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

5/18/2018

Front Range Kratom

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

5/18/2018

Revibe, Inc.

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

5/18/2018

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

Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

 

 

 

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Page Last Updated: 08/14/2018
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