FDA Warning Letters : Pharmaceutical Guidelines

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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 2019
Date Issued to Company Country
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

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