FDA Warning Letters

We list here warning letters issued by FDA to pharmaceutical manufacturing facilities. You can check the details of warning letter by clicking on the name of the company.

Warning Letters Issued in 2022

Date	Issued to Company	Country
06/12/2022	Glenmark Pharmaceuticals Limited	India
08/11/2022	Abraxis Bioscience LLC	United States
01/11/2022	Lupin Limited	India
27/09/2022	Zhejiang Tianyu Pharmaceutical Co., Ltd.	China
26/04/2022	Guangzhou Zhongkebaishi Health Industry Co., Ltd.	China
12/01/2022	Aurobindo Pharmaceutical Limited	India
06/01/2022	Cosmo Bio Co., Ltd.	South Korea

Warning Letters Issued in 2021

Date	Issued to Company	Country
23/11/2021	Hubei Kangzheng Pharmaceutical Co., Ltd.	China
30/09/2021	GuangZhou YouXing Cosmetic Co., Ltd	China
10/08/2021	BBC Group Limited	China
25/05/2021	Biotek India	India
16/03/2021	Foshan Biours Biosciences Co., Ltd.	China
09/02/2021	ShangRao Chunyu Technology Co., Ltd.	China
26/01/2021	Yuyao YiJia Daily Chemical Co., Ltd.	China

Warning Letters Issued in 2020

Date	Issued to Company	Country
22/12/2020	G & L Wellness, LLC	United States
27/10/2020	Shilpa Medicare Limited	India
06/10/2020	LEC Custom Products, Inc.	Canada
29/09/2020	Panacea Biotec Limited	India
15/09/2020	Mayon's Pharmaceuticals Pvt Ltd	India
08/09/2020	PT. MegaSurya Mas	Indonesia
25/08/2020	Wintac Limited	United States
27/07/2020	Eskbiochem SA de CV	Mexico
21/07/2020	Signa SA de CV	Canada
07/07/2020	Vega Life Sciences Private Limited	India
16/06/2020	Cosmaceutical Research Lab Inc.	Canada
16/06/2020	Takeda Pharmaceutical Company Limited	Japan
26/05/2020	Samchundang Pharm Co., Ltd.	South Korea
19/05/2020	Kumar Organic Products Limited	India
31/03/2020	FICOSOTA LTD	Bulgaria
31/03/2020	Pfizer Healthcare India Private Limited	India
24/03/2020	DermaPharm A/S	Denmark
24/03/2020	Hangzhou Linkeweier Daily Chemicals Co., Ltd.	China
17/03/2020	Cipla Limited	India
17/03/2020	Windlas Healthcare Private Limited	India
10/03/2020	Guangzhou Tinci Materials Technology Co., Ltd.	China
03/03/2020	Chemland Co., Ltd.	South Korea
25/02/2020	JHS Svendgaard Hygiene Products Ltd	India
25/02/2020	Essnd Global	India
28/01/2020	Baja Fur S.A. de C.V.	United States
28/01/2020	Dental-Kosmetik GmbH & Co. KG	Germany
28/01/2020	Sunstar Guangzhou Ltd.	China
21/01/2020	Cosmelab Co. Ltd.	South Korea
21/01/2020	Zhuhai Aofute Medical Technology Co., Ltd.	China
21/01/2020	CGA Limited	Trinidad & Tobago
21/01/2020	Tismor Health and Wellness Pty Limited	Australia
14/01/2020	Huaian Zongheng Bio-Tech Co., Ltd	China
07/01/2020	Apollo Health And Beauty Care, Inc.	Canada

Warning Letters Issued in 2019

Date	Issued to Company	Country
31/12/2019	Henan Kangdi Medical Devices Co. Ltd	China
31/12/2019	GPT Pharmaceuticals Private Ltd	India
17/12/2019	Wild Child WA Pty Ltd.	Australia
11/12/2019	Alkermes, Inc.	United States
12/11/2019	Cadila Healthcare Limited	India
12/11/2019	Mylan Laboratories Limited	India
05/11/2019	Bingbing Pharmaceutical Co. Ltd.	China
09/10/2019	Coral Pharmaceuticals Limited	Bahamas
08/10/2019	Torrent Pharmaceuticals Limited	India
03/10/2019	Glenmark Pharmaceuticals Limited	India
12/09/2019	Dermameal Co., Ltd.	South Korea
10/09/2019	Lupin Ltd.	India
29/08/2019	Hangzhou Badi Daily Use Chemical Company	China
22/08/2019	Polimeros y Servicios S.A.	Costa Rica
19/08/2019	Haw Par Healthcare Limited	Singapore
16/08/2019	Metuchen Pharmaceuticals, LLC.	United States
15/08/2019	Enprani Co., Ltd.	South Korea
12/08/2019	Yino, Inc.	China
08/08/2019	Lantech Pharmaceuticals Limited	India
02/08/2019	NingBo Huize Commodity Co., Ltd.	China
02/08/2019	Emcure Pharmaceuticals Limited	India
16/07/2019	Indoco Remedies Limited	India
12/07/2019	CTX Lifesciences Private Ltd.	India
01/07/2019	Strides Pharma Science Limited	India
20/06/2019	Aurobindo Pharma Limited	India
13/06/2019	Rxhomeo Private Limited	India
29/05/2019	Vida International, Inc.	Taiwan
07/05/2019	Petra Hygienic Systems Int Ltd	Canada
04/05/2019	Centurion Laboratories Private Limited	India
23/04/2019	Laboratoires Clarins	France
04/04/2019	Luen Fook Medicine Sdn. Bhd.	Singapore
21/03/2019	B. Jain Pharmaceuticals Private Limited	India
18/03/2019	Dong Yuan Technology Co., Ltd.	China
06/03/2019	Jubilant Generics Limited	India
04/03/2019	Hospira Healthcare India Pvt. Ltd.	India
28/02/2019	Anicare Pharmaceuticals Pvt Ltd.	India
25/02/2019	Laboratorios Quantium LLC	United States
25/02/2019	Vilvet Pharmaceutical	United States
13/02/2019	Proandre SL	Spain
29/01/2019	Hangzhou SunKing Nonwovens Co., Ltd.	China
29/01/2019	Vipor Chemicals Private Ltd.	India
10/01/2019	Vitalab Pharmacy, Inc.	United States

Warning Letters Issued in 2018

Date	Issued to Company	Country
14/12/2018	Longbow First Aid Products Manufactory	China
14/12/2018	Hangzhou Guoguang Touring Commodity Co.,Ltd.	China
13/12/2018	Samson Pharmaceuticals, Inc	United States
13/12/2018	Soleo	South Korea
03/12/2018	Skylark CMC Pvt. Ltd.	India
30/11/2018	Cao Medical Equipment Co., Ltd.	China
29/11/2018	Zhejiang Huahai Pharmaceutical	China
28/11/2018	Barox Co., Ltd.	South Korea
27/11/2018	Hangzhou Zhongbo Industrial Co., Ltd.	China
09/11/2018	Mylan Pharmaceuticals, Inc.	United States
22/10/2018	Vanda Pharmaceuticals	United States
03/10/2018	Hanlim Pharm Co., Ltd.	South Korea
24/09/2018	N-Molecular Inc. d.b.a. SOFIE	United States
10/09/2018	Wilson Medicine Company	India
05/09/2018	Jabones Y Productos Especializados SA de CV	Mexico
04/09/2018	Lernapharm (Loris) Inc.	Canada
27/08/2018	Longood Medicine (Beijing) Co Ltd	China
10/08/2018	Kyowa Hakko Bio Co., Ltd.	Japan
09/08/2018	Apotex Research Private Limited	India
01/08/2018	Bill Beauty and Health Products Ltd.	Canada
31/07/2018	Hangzhou Karic Commodities Co., Ltd.	China
27/07/2018	JT Cosmetics & Chemicals Pvt Ltd.	India
26/07/2018	Yicheng Goto Pharmaceuticals Co., Ltd	China
24/07/2018	Les Produits Chimiques B.G.R., Inc.	Canada
17/07/2018	Yuki Gosei Kogyo Co., Ltd.	Japan
05/07/2018	Claris Injectables Limited	India
27/06/2018	Zhuhai United Laboratories Co. Ltd.	China
26/06/2018	Foshan Jinxiong Technology Co., Ltd.	China
22/06/2018	Sichuan Friendly Pharmaceutical Co., Ltd.	China
12/06/2018	Henan Lihua Pharmaceutical Co., Ltd.	China
08/06/2018	BR SAS	France
31/05/2018	Taiwan Biotech Co., LTD.	Taiwan
23/05/2018	IDT Australia Ltd.	Australia
18/05/2018	Kolmar Korea Co. Ltd.	South Korea
18/05/2018	Jalco Cosmetics Pty Ltd.	Australia
16/05/2018	Europharma Concepts Limited	Ireland
14/05/2018	Jilin Shulan Synthetic Pharmaceutical Co. Ltd.	China
09/05/2018	Nox Bellcow Cosmetics Co. Ltd.	China
09/05/2018	Reine Lifescience	India
24/04/2018	Goran Pharma Pvt Ltd	India
19/04/2018	Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd.	China
18/04/2018	Degasa S.A. De C.V.	Mexico
09/04/2018	McCallum Manufacturing Ltd	United Kingdom
06/04/2018	Luen Wah (HK) Medicine Ltd	China
29/03/2018	Hanbul Cosmetics Co., Ltd	Korea
15/03/2018	Keshava Organics Pvt. Ltd.	India
09/03/2018	Malladi Drugs & Pharmaceuticals Ltd.	India
05/03/2018	Quali Controle & Qual-Controle-C.E.Bac	France
23/02/2018	Zhejiang Ludao Technology Co., Ltd.	China
23/02/2018	Nan San (HK) Pharmaceutical Factory Ltd.	China
16/02/2018	Alchymars ICM SM Private Limited	India
14/02/2018	Nowcos Co., Ltd	South Korea
12/02/2018	Casmara Cosmetics, S.A.	Spain
07/02/2018	Shanghai Weierya Daily Chemicals Factory	China
02/02/2018	Cosmecca Korea Co., Ltd.	North Korea
26/01/2018	Celltrion Inc.	South Korea
25/01/2018	Polaroisin International Co., Ltd.	Taiwan
18/01/2018	Daito Kasei Kogyo Co Ltd	Japan
11/01/2018	King Bio Inc.	United States
11/01/2018	Guna Inc.	United States
11/01/2018	Wong Lap Kwong Medicine Company Limited	China
09/01/2018	Hunan Norchem Pharmaceutical Co. Ltd.	China
01/01/2018	Yicheng Chemical Corp.	China