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.
- Office of Prescription Drug Promotion Letters
- Office of Compliance/Immediate Office
- Office of Manufacturing Quality Letters
- Office of Scientific Investigations Letters
- Office of Unapproved Drugs and Labeling Compliance
- Office of Drug Security, Integrity and Recalls
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 |
|---|---|---|
|
Vanda Pharmaceuticals Inc.
|
NDA 022192 FANAPT (iloperidone) tablets, for oral use NDA 205677 HETLIOZ (tasimelteon) capsules, for oral use |
10/22/2018 |
|
Eisai Inc.
|
NDA 202834; 208277 Fycompa (perampanel) oral suspension, CIII Fycompa(perampanel) tablets, for oral use, CIII |
10/11/2018 |
|
MannKind Corporation
|
NDA 022472 Afrezza (insulin human) inhalation powder, for oral inhalation use |
10/5/2018 |
|
ASCEND Therapeutics US, LLC
|
NDA 021166 EstroGel 0.06% (estradiol gel) for topical use |
8/16/2018 |
|
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 |
Office of Compliance/Immediate Office
|
Company/Individual |
Product/Issue |
Issue Date |
|---|---|---|
|
Netcos Co. Ltd. |
Listing information provided for P8 Tone - Up and Brightening Creamex, NDC 71738-0007 |
10/29/2018 |
|
United Exchange Corp. |
Listing information provided for Family Care Antibiotic, NDC 65923-051 |
10/29/2018 |
|
AMI Cosmetic Co., Ltd. |
Listing information provided for PureHeals Centella 70 Toning Swab, NDC 59535-0268 |
6/12/2018 |
Office of Manufacturing Quality
|
Company/Individual |
Product/Issue |
Issue Date |
|---|---|---|
|
Hangzhou Guoguang Touring Commodity Co., Ltd. |
CGMP/Finished Pharmaceuticals/Adulterated |
12/14/2018 |
|
Longbow First Aid Products Manufactory
|
CGMP/Finished Pharmaceuticals/Adulterated |
12/14/2018 |
|
Soleo |
CGMP/Finished Pharmaceuticals/Adulterated |
12/13/2018 |
Skylark CMC Pvt. Ltd.
|
Firm limited and/or refused an FDA inspection |
12/3/2018 |
|
Zhejiang Huahai Pharmaceutical Co., Ltd |
CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated |
11/29/2018 |
|
Barox Co., Ltd. |
CGMP/Finished Pharmaceuticals/Adulterated |
11/28/2018 |
|
Hanlim Pharm Co., Ltd. |
CGMP/Finished Pharmaceuticals/Adulterated |
10/3/2018 |
|
Wilson Medicine Company |
CGMP/Finished Pharmaceuticals/Adulterated |
9/11/2018 |
|
Jabones Y Productos Especializados SA de CV |
CGMP/Finished Pharmaceuticals/Adulterated |
9/5/2018 |
|
Lernapharm (Loris) Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |
9/4/2018 |
|
Longood Medicine (Beijing) Co., Ltd. |
CGMP/Finished Pharmaceuticals/Adulterated |
8/27/2018 |
|
Kyowa Hakko Bio Co., Ltd. |
CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated |
8/10/2018 |
|
Apotex Research Private Limited |
CGMP/Finished Pharmaceuticals/Adulterated |
8/9/2018 |
|
Bill Beauty and Health Products Ltd. |
CGMP/Finished Pharmaceuticals/Adulterated |
8/1/2018 |
|
Hangzhou Karic Commodities Co., Ltd. |
CGMP/Finished Pharmaceuticals/Adulterated |
7/31/2018 |
|
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 |
|
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 |
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 |
|---|---|---|
|
|
|
|