FDA Warning Letters : Pharmaguideline

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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 2024
Date Issued to Company Country
13/02/2024 Madhu Instruments Private Limited India
06/02/2024 Les Importations Herbasanté Inc. Canada
30/01/2024 S & J International Enterprises Public Company Limited Thailand
23/01/2024 Glicerinas Industriales, S.A. de C.V. Mexico
12/01/2024 Nantong Furuida Packaging Products Co., Ltd. China
09/01/2024 Woorilife & Health South Korea

Warning Letters Issued in 2023
Date Issued to Company Country
26/12/2023 Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi Turkey
01/08/2023 Intas Pharmaceuticals Limited India
01/08/2023 Baxter Healthcare Corporation United States
01/08/2023 Medgel Private Limited India
01/08/2023 Centaur Pharmaceuticals Private Ltd. India
18/07/2023 Centaur Pharmaceuticals Private Ltd. India
25/04/2023 Pharmaplast S.A.E. Egypt
18/04/2023 Zermat International S.A. de C.V. Mexico
14/02/2023 Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil Turkey
30/01/2023 Fei Fah Medical Manufacturing Pte. Ltd. Singapore

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

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