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  6. Warning Letters 2019
  1. Enforcement Activities by FDA

Warning Letters 2019

Warning Letters 2019

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 Freedom of Information Page.

Office of Prescription Drug Promotion

Company/Individual

Product/Issue

Issue Date

Metuchen Pharmaceuticals, LLC

NDA 202276 STENDRA (avanafil) tablets, for oral use 8/16/2019

CooperSurgical, Inc.

NDA 018680 ParaGard T380A INTRAUTERINE COPPER CONTRACEPTIVE 7/25/2019

Aclaris Therapeutics, Inc.

NDA 209305 ESKATA (hydrogen peroxide) topical solution 6/14/2019

VIVUS, Inc.

NDA 022580 QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIV

5/22/2019

Phoenix Molecular Imaging Center

Sodium Acetate (C-11) 2/15/2019

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Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

diphenhydramine hydrochloride and zinc acetate, NDC 41520-090; failure to address the listing deficiencies detailed in FDA’s letter to your company on March 19, 2019

7/11/2019

Yuyao Jessie Commodity Co., Ltd.

Mouth Fresh, NDC 51414-501/ failure to fulfill listing obligations 4/18/2019

ABC Compounding Co., Inc. 

 Santi Wash Antiseptic Hand Wash, NDC 62257-275/ failure to fulfill listing obligations 4/18/2019

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Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

Lantech Pharmaceuticals Limited

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 8/8/2019

NingBo Huize Commodity Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 8/2/2019

Deva Holding AS - Cerkezkoy Subesi

CGMP/Finished Pharmaceuticals/Adulterated 8/6/2019

Emcure Pharmaceuticals Limited

CGMP/Finished Pharmaceuticals/Adulterated 8/2/2019

Indoco Remedies Limited

CGMP/Finished Pharmaceuticals/Adulterated 7/9/2019
CGMP/Finished Pharmaceuticals/Adulterated 7/1/2019
CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 6/20/2019

Rxhomeo Private Limited

CGMP/Finished Pharmaceuticals/Adulterated 6/13/2019

Xi'an Livingbond Nonwoven Products Corp., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 6/10/2019

Glint Cosmetics Pvt. Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 5/31/2019

Vida International, Inc.

CGMP/Finished Pharmaceuticals/Adulterated 5/29/2019
CGMP/Finished Pharmaceuticals/Adulterated 5/7/2019

Centurion Laboratories Private Limited

CGMP/Finished Pharmaceuticals/Adulterated 5/4/2019

Laboratoires Clarins

CGMP/Finished Pharmaceuticals/Adulterated 4/23/2019

Luen Fook Medicine Sdn., Bhd.

CGMP/Finished Pharmaceuticals/Adulterated 4/4/2019

B. Jain Pharmaceuticals Private Limited

CGMP/Finished Pharmaceuticals/Adulterated 3/21/2019

Dong Yuan Technology Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

3/18/2019

Jubilant Life Sciences

CGMP/Finished Pharmaceuticals/Adulterated

3/6/2019

Hospira Healthcare India Pvt. Ltd

CGMP/Finished Pharmaceuticals/Adulterated 3/4/2019

Anicare Pharmaceuticals Pvt. Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 2/28/2019

Proandre SL

CGMP/Finished Pharmaceuticals/Adulterated

2/13/2019

Vipor Chemicals Private Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

1/29/2019

Hangzhou Sunking Nonwovens Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

1/29/2019

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Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

Lymol Medical Corp

Postmarket Requirements (PMRs) 1/8/2019

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Office of Unapproved Drugs and Labeling Compliance

Company/Individual

Product/Issue

Issue Date

Curaleaf, Inc

Unapproved New Drugs/Misbranded 7/22/2019

Cali Botanicals, LLC

Unapproved New Drugs/Misbranded 6/11/2019

Kratom NC

Unapproved New Drugs/Misbranded 5/16/2019

/Advanced Spine and Pain, LLC (d/b/a Relievus)/

Unapproved New Drugs/Misbranded 3/28/2019

Nutra Pure LLC

Unapproved New Drugs/Misbranded 3/28/2019

Nutra Pharma Corp.

Unapproved New Drugs/Misbranded

3/19/2019

 Aidaccess

Unapproved New Drugs/Misbranded 3/8/2019

Rablon

Unapproved New Drugs/Misbranded 3/8/2019

Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

 

 

 

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