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  6. Warning Letters 2020
  1. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Warning Letters 2020

These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion 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 Freedom of Information Page.

Office of Prescription Drug Promotion

Company/Individual

Product/Issue

Issue Date

Outlook Pharmaceuticals, Inc.

ANDA 040776 PROCENTRA® (dextroamphetamine sulfate) oral solution, CII

2/21/2020

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Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

 

   

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Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

Yibin Lihao Bio-technical Co., Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 2/13/2020

Sunstar Guangzhou Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 1/22/2020

Dental-Kosmetik GmbH & Co. KG

CGMP/Finished Pharmaceuticals/Adulterated 1/16/2020

Cosmelab Co Ltd

CGMP/Finished Pharmaceuticals/Adulterated 1/9/2020

Zhuhai Aofute Medical Technology Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 1/9/2020

Huaian Zongheng Bio-Tech Co., Ltd

CGMP/Finished Pharmaceuticals/Adulterated 1/9/2020

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Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

 

   

 

Office of Unapproved Drugs and Labeling Compliance

Company/Individual

Product/Issue

Issue Date

 

             

Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

 

   

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