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

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



Issue Date

Kowa Pharmaceuticals, Inc.

NDA 022363 Livalo (pitavastatin) tablet, for oral use 9/24/2019

Galt Pharmaceuticals, LLC

NDA 018708 DORAL (quazepam) tablets for oral use C-IV 9/13/2019

Metuchen Pharmaceuticals, LLC

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

CooperSurgical, Inc.


Aclaris Therapeutics, Inc.

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


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


Phoenix Molecular Imaging Center

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

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Office of Compliance/Immediate Office 



Issue Date

NuCare Pharmaceuticals Inc

non-compliance with listing obligations 9/26/2019

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


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



Issue Date

Torrent Pharmaceuticals Limited

GMP/Finished Pharmaceuticals/Adulterated 10/8/2019

Glenmark Pharmaceuticals Limited

GMP/Finished Pharmaceuticals/Adulterated 10/3/2019

Dermameal Co., Ltd.

CGMP/Finished Pharmaceuticals 9/12/2019

Jiangsu NHWA Pharmaceutical Co., Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 9/10/2019

Lupin Limited

CGMP/Finished Pharmaceuticals/APIs/Adulterated 9/10/2019

Shanghai Institute of Pharmaceutical Industry

CGMP/APIs 8/29/2019

Polimeros y Servicios S.A.

GMP/adulterated 8/22/2019

Haw Par Healthcare Limited

GMP/adulterated 8/19/2019

Ningbo Pulisi Daily Chemical Products Co., Ltd

CGMP/Finished Pharmaceuticals/Adulterated 8/13/2019

Yino, Inc.

GMP/adulterated 8/12/2019

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

CTX Lifesciences Private Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 7/12/2019

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


Jubilant Life Sciences

CGMP/Finished Pharmaceuticals/Adulterated


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


Vipor Chemicals Private Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated


Hangzhou Sunking Nonwovens Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated


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Office of Scientific Investigations



Issue Date

Lymol Medical Corp

Postmarket Requirements (PMRs) 1/8/2019


Office of Unapproved Drugs and Labeling Compliance



Issue Date

Rooted Apothecary LLC

“Teeth/TMJ – Essential Oil + CBD Infusion,” “Ears – Essential Oil + CBD Infusion,” “Hemp Capsules, 750 mg,” “Hemp Infused Body Butter,” and “Hemp Oil”/unapproved new drugs 10/10/2019

illegally marketing unapproved and misbranded versions of opioid medicines


Polimeros y Servicios S.A.

Unapproved drugs/misbranded 8/22/2019

Haw Par Healthcare Limited

Unapproved drugs/misbranded 8/19/2019

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



Unapproved New Drugs/Misbranded 3/8/2019

Office of Drug Security, Integrity and Recalls



Issue Date


Unapproved drugs/misbranded  3/8/2019

CanaRx Services Inc.

Unapproved drugs/misbranded 


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