| Company Name | Country | Regulator | Regulatory Action | Issue Date | Date of Inspection | Facility Type | Data-Integrity Citation |
|---|---|---|---|---|---|---|---|
| Accelerated Analytical Laboratories Inc. | United States | FDA | Warning Letter | October 18, 2017 | May 8 to 12, 2017 | Finished Pharmaceuticals | |
| Amaros Co., Ltd | Korea | FDA | Warning Letter | December 13, 2017 | May 8 to 12, 2017 | Finished Pharmaceuticals | |
| AN Co. Ltd. | Korea | FDA | Warning Letter | December 13, 2017 | May 29 to 30, 2017 | Finished Pharmaceuticals | |
| Ausmetics Daily Chemicals (Guangzhou) Co., Ltd | China | FDA | Warning Letter | January 31, 2017 | July 25 to 29, 2016 | Finished Pharmaceuticals | |
| Aztex Enterprises Ltd | Canada | FDA | Warning Letter | October 20, 2017 | June 12 to June 13, 2017 | Finished Pharmaceuticals | |
| B. Braun Medical Inc | United States | FDA | Warning Letter | May 12, 2017 | April 18 to May 11, 2016 | Finished Pharmaceuticals | |
| Badrivishal Chemicals & Pharmaceuticals | India | FDA | Warning Letter | March 2, 2017 | August 16 to 19, 2016 | Active Pharmaceutical Ingredients | Yes |
| Bicooya Cosmetics Limited | China | FDA | Warning Letter | August 11, 2017 | May 22 to 25, 2017 | Finished Pharmaceuticals | Yes |
| C. O. Truxton Inc. | United States | FDA | Warning Letter | December 19, 2017 | April 17 to June 1, 2017 | Finished Pharmaceuticals | |
| Cellex-C International Inc | Canada | FDA | Warning Letter | August 2, 2017 | January 16 to 19, 2017 | Finished Pharmaceuticals | |
| Changzhou Jintan Qianyao Pharmaceutical Raw Materials | China | FDA | Warning Letter | May 11, 2017 | February 13 to 17, 2017 | Active Pharmaceutical Ingredients | |
| ChemRite CoPac, Inc. | United States | FDA | Warning Letter | June 29, 2017 | June 6 to July 15, 2016 | Finished Pharmaceuticals | |
| Chongqing Pharma Research Institute Co., Ltd. | China | FDA | Warning Letter | February 14, 2017 | May 16 to 19, 2016 | Active Pharmaceutical Ingredients | Yes |
| Cixi Zhixin Bird Clean-Care Product Co., Ltd. | China | FDA | Warning Letter | January 6, 2017 | May 3 to 6, 2016 | Finished Pharmaceuticals | |
| CTX Lifesciences Private Ltd. | India | FDA | Warning Letter | January 18, 2017 | February 15 to 19, 2016 | Active Pharmaceutical Ingredients | |
| Dae Young Foods Co., Ltd. | Korea | FDA | Warning Letter | November 20, 2017 | March 13 to 17, 2017 | Finished Pharmaceuticals | |
| Dasan E&T Co., Ltd. | Korea | FDA | Warning Letter | September 22, 2017 | January 23 to 26, 2017 | Finished Pharmaceuticals | |
| Deserving Health International Corp | Canada | FDA | Warning Letter | December 18, 2017 | July 10 to 14, 2017 | Finished Pharmaceuticals | |
| Divi's Laboratories | India | FDA | Warning Letter | April 13, 2017 | November 29 to December 6, 2016 | Active Pharmaceutical Ingredients | Yes |
| FACTA Farmaceutici S.p.A. | Italy | FDA | Warning Letter | January 13, 2017 | January 11 to 19, 2016 | Finished Pharmaceuticals | Yes |
| Firson Co., Ltd. | Korea | FDA | Warning Letter | August 31, 2017 | November 3 to 11, 2016 | Finished Pharmaceuticals | |
| Foshan Flying Medical Products Co., Ltd. | China | FDA | Warning Letter | August 1, 2017 | February 20 to 23, 2017 | Finished Pharmaceuticals | |
| Fresenius Kabi Oncology Ltd | Germany | FDA | Warning Letter | December 4, 2017 | May 15 to May 24, 2017 | Active Pharmaceutical Ingredients | |
| Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. | China | FDA | Warning Letter | October 30, 2017 | May 15 to 19, 2017 | Finished Pharmaceuticals | |
| Hangzhou Facecare Cosmetics Co., Ltd. | China | FDA | Warning Letter | November 17, 2017 | June 19 to 22, 2017 | Finished Pharmaceuticals | |
| Hetero Labs Limited | India | FDA | Warning Letter | August 15, 2017 | December 7 to 16, 2016 | Finished Pharmaceuticals | |
| Homeocare Laboratories, Inc. | United States | FDA | Warning Letter | September 7, 2017 | January 4 to 11, 2017 | Finished Pharmaceuticals | |
| Homeolab USA Inc. | Canada | FDA | Warning Letter | August 2, 2017 | January 9 to 13, 2017 | Finished Pharmaceuticals | |
| Hospira Inc | United States | FDA | Warning Letter | February 14, 2017 | May 16 to June 8, 2016 | Finished Pharmaceuticals | |
| Hubei Danao Pharmaceutical Co., Ltd. | China | FDA | Warning Letter | November 6, 2017 | July 31 to August 4, 2017 | Active Pharmaceutical Ingredients | |
| Humco Holding Group, Inc | United States | FDA | Warning Letter | January 26, 2017 | June 25 to July 1, 2015 | Finished Pharmaceuticals | |
| Huron Pharmaceuticals, Inc. | United States | FDA | Warning Letter | April 20, 2017 | December 13 to 22, 2016 | Active Pharmaceutical Ingredients | |
| Indoco Remedies Limited | India | FDA | Warning Letter | March 27, 2017 | August 31 to September 4, 2016 | Finished Pharmaceuticals | |
| Jinan Jinda Pharmaceutical Chemistry Co., Ltd. | China | FDA | Warning Letter | February 24, 2017 | May 30 to June 1, 2016 | Active Pharmaceutical Ingredients | Yes |
| Lumis Global Pharmaceuticals | China | FDA | Warning Letter | March 2, 2017 | September 26 to 28, 2016 | Active Pharmaceutical Ingredients | |
| Lupin Limited | India | FDA | Warning Letter | November 6, 2017 | March 27 to April 7, 2017 & May 8 to May 19, 2017 | Finished Pharmaceuticals | |
| Med-Pharmex, Inc. | United States | FDA | Warning Letter | May 17, 2017 | January 17 to February 1, 2017 | Finished Pharmaceuticals | |
| Megafine Pharma (P) Limited | India | FDA | Warning Letter | February 24, 2017 | September 19 to 23, 2016 | Active Pharmaceutical Ingredients | Yes |
| Morton Grove Pharmaceuticals, Inc. | United States | FDA | Warning Letter | February 17, 2017 | January 4 to February 5, 2016 | Finished Pharmaceuticals | Yes |
| Mylan Laboratories Limited | India | FDA | Warning Letter | April 3, 2017 | September 5 to 14, 2016 | Finished Pharmaceuticals | Yes |
| Nova Homeopathic Therapeutics Inc | United States | FDA | Warning Letter | September 1, 2017 | October 3 to 12, 2016 | Finished Pharmaceuticals | |
| Pharmaceutic Labs, LLC. | United States | FDA | Warning Letter | May 3, 2017 | August 31 to September 23, 2015 | Finished Pharmaceuticals | |
| Phillips Co. | United States | FDA | Warning Letter | May 8, 2017 | October 4 to 7, 2016 | Finished Pharmaceuticals | |
| Porton Biopharma Limited | United Kingdom | FDA | Warning Letter | January 19, 2017 | March 7 to 18, 2016 | Active Pharmaceutical Ingredients | |
| Qinhuangdao Zizhu Pharmaceutical | China | FDA | Warning Letter | April 24, 2017 | November 28 to December 1, 2016 | Active Pharmaceutical Ingredients | Yes |
| Raritan Pharmaceuticals, Inc. | United States | FDA | Warning Letter | June 20, 2017 | September 29 to October 20, 2016 | Finished Pharmaceuticals | |
| Resonance Laboratories Private Limited | India | FDA | Warning Letter | February 3, 2017 | May 2 to 6, 2016 | Active Pharmaceutical Ingredients | |
| Sage Products Inc | United States | FDA | Warning Letter | July 17, 2017 | June 2 to September 1, 2016 | Finished Pharmaceuticals | |
| Sal Pharma | India | FDA | Warning Letter | April 20, 2017 | June 27 to July 1, 2016 | Active Pharmaceutical Ingredients | |
| Sato Pharmaceutical Co., Ltd. | Japan | FDA | Warning Letter | February 2, 2017 | February 8 to 12, 2016 | Finished Pharmaceuticals | |
| Sato Yakuhin Kogyo Co., Ltd. | Japan | FDA | Warning Letter | January 6, 2017 | June 6 to 10, 2016 | Finished Pharmaceuticals | Yes |
| Seindni Co., Ltd. | Korea | FDA | Warning Letter | December 5, 2017 | May 25 to 26, 2017 | Finished Pharmaceuticals | |
| Shandong Analysis and Test Center | China | FDA | Warning Letter | June 22, 2017 | January 16 to 18, 2017 | Active Pharmaceutical Ingredients | |
| Shandong Vianor Biotech Co., Ltd. | China | FDA | Warning Letter | September 12, 2017 | May 8 to 10, 2017 | Finished Pharmaceuticals | |
| Suzhou Pharmaceutical Technology Co.,Ltd | China | FDA | Warning Letter | January 6, 2017 | June 6 to 8, 2016 | Active Pharmaceutical Ingredients | |
| Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. | China | FDA | Warning Letter | April 5, 2017 | September 26 to 29, 2016 | Active Pharmaceutical Ingredients | |
| Tubilux Pharma Spa | Italy | FDA | Warning Letter | July 6, 2017 | December 1 to 9, 2016 | Finished Pharmaceuticals | |
| USV Limited | India | FDA | Warning Letter | March 10, 2017 | June 1 to 10, 2016 | Finished Pharmaceuticals | Yes |
| Vikshara Trading & Investments | India | FDA | Warning Letter | April 28, 2017 | October 18, 2016 | Finished Pharmaceuticals | |
| Vista Pharmaceuticals Limited | India | FDA | Warning Letter | July 5, 2017 | September 19 to 23, 2016 | Finished Pharmaceuticals | |
| Vital Laboratories Pvt Ltd | India | FDA | Warning Letter | October 10, 2017 | April 3 to 6, 2017 | Active Pharmaceutical Ingredients | |
| Wuxi Medical lnstrument Factory | China | FDA | Warning Letter | September 7, 2017 | March 6 to 10, 2017 | Finished Pharmaceuticals | |
| Yusef Manufacturing Laboratories, LLC | United States | FDA | Warning Letter | May 25, 2017 | May 23 to 26, 2016 | Finished Pharmaceuticals | |
| Zhejiang Bangli Medical Products | China | FDA | Warning Letter | January 26, 2017 | August 16 to 17, 2016 | Finished Pharmaceuticals | |
| Ridge Properties, LLC | United States | FDA | Warning Letter | October 13, 2017 | February 28 to March 16, 2017 | Finished Pharmaceuticals | |
| Skin Sciences Laboratory, Inc. | Philippines | FDA | Warning Letter | July 28, 2017 | January 30 to February 1, 2017 | Finished Pharmaceuticals | |
| Bristol Laboratories Limited | United Kingdom | EDQM | Non-Compliance | October 2, 2017 | July 17, 2017 | Finished Pharmaceuticals | |
| Bristol Laboratories Limited | United Kingdom | EDQM | Non-Compliance | August 24, 2017 | July 17, 2017 | Finished Pharmaceuticals | Yes |
| Bristol Laboratories Limited | United Kingdom | EDQM | Non-Compliance | August 24, 2017 | April 24, 2017 | Finished Pharmaceuticals | Yes |
| Gopaldas Visram & Co. Ltd. | India | EDQM | Non-Compliance | August 29, 2017 | May 17, 2017 | Finished Pharmaceuticals | Yes |
| Hyperion SA | Romania | EDQM | Non-Compliance | December 11, 2017 | June 23, 2017 | Finished Pharmaceuticals | |
| Apotex Research Private Limited | India | EDQM | Non-Compliance | December 8, 2017 | November 17, 2017 | Finished Pharmaceuticals | |
| The Acme Laboratories Limited | Bangladesh | EDQM | Non-Compliance | December 11, 2017 | November 8, 2017 | Finished Pharmaceuticals | Yes |
| EuroPharma.DK ApS | Denmark | EDQM | Non-Compliance | November 8, 2017 | September 21, 2017 | Finished Pharmaceuticals | |
| Evertogen Life Sciences Limitedn | India | EDQM | Non-Compliance | October 18, 2017 | August 31, 2017 | Finished Pharmaceuticals | Yes |
| Dr. Reddy's Laboratories | India | EDQM | Non-Compliance | August 8, 2017 | August 1, 2017 | Finished Pharmaceuticals | |
| Shilpa Medicare Limited | India | FDA | 483 | November 30, 2017 | November 20 to 30, 2017 | Active Pharmaceutical Ingredients | |
| Glenmark Pharmaceuticals Ltd. | India | FDA | 483 | November 11, 2017 | November 6 to 11, 2017 | Finished Pharmaceuticals | |
| Claris Injectables Ltd. | India | FDA | 483 | August 4, 2017 | July 27 to August 4, 2017 | Finished Pharmaceuticals | |
| Divi's Laboratories | India | FDA | 483 | September 19, 2017 | September 11 to 19, 2017 | Active Pharmaceutical Ingredients | |
| Aurobindo Pharma | India | FDA | 483 | September 1, 2017 | August 28 to September 1, 2017 | Finished Pharmaceuticals | |
| Dr. Reddy's Laboratories | United Kingdom | FDA | 483 | September 15, 2017 | September 11 to 15, 2017 | Active Pharmaceutical Ingredients | |
| Celltrion | Korea | FDA | 483 | June 2, 2017 | May 29 to June 2, 2017 | API & FDF | |
| Shanghai Kejing Cleaning Products Co. Ltd. | China | FDA | Import Alert 99-32 | October 20, 2017 | Not Available | ||
| Hubei Merryclin Pharmaceutical Co., Ltd. | China | FDA | Import Alert 99-32 | September 28, 2017 | Not Available | ||
| Jiangsu Terra Medical Technology Co. Ltd. | China | FDA | Import Alert 99-32 | October 11, 2017 | Not Available | ||
| Shijiazhuang Polee Pharmaceutical Co., Ltd. | China | FDA | Import Alert 99-32 | November 27, 2017 | Not Available | ||
| Tianjin Zhongxin Pharmaceutical Group Corp., Ltd. | China | FDA | Import Alert 99-32 | September 19, 2017 | Not Available | ||
| Wendeng Jinye Industrial Co., Ltd. | China | FDA | Import Alert 99-32 | November 2, 2017 | Not Available | ||
| Wuhan Fulai Pharmaceutical Technology Co.,Ltd | China | FDA | Import Alert 99-32 | September 26, 2017 | Not Available | ||
| Yixing City Xingyu Medicine Chemicals Co Ltd | China | FDA | Import Alert 99-32 | October 10, 2017 | Not Available | ||
| Alex Industries | India | FDA | Import Alert 99-32 | September 13, 2017 | Not Available | ||
| Basic Pharma Life Science Private Ltd. | India | FDA | Import Alert 99-32 | October 10, 2017 | Not Available | ||
| Kronox Lab Sciences Private Ltd. | India | FDA | Import Alert 99-32 | November 17, 2017 | Not Available | ||
| Mahrshee Laboratories Private Ltd. | India | FDA | Import Alert 99-32 | November 22, 2017 | Not Available | ||
| Ming Fai Industrial (Shenzhen) Co LTD | China | FDA | Import Alert 66-40 | December 21, 2017 | Not Available | ||
| Delta Laboratories Pty | Australia | FDA | Import Alert 66-40 | September 28, 2017 | Not Available | ||
| Schrofner Cosmetics Gmbhn | Austria | FDA | Import Alert 66-40 | October 20, 2017 | Not Available | ||
| Aztex Enterprises Ltd | Canada | FDA | Import Alert 66-40 | October 19, 2017 | Not Available | ||
| Deserving Health International Corp | Canada | FDA | Import Alert 66-40 | November 2, 2017 | Not Available | ||
| Ross Healthcare Inc. | Canada | FDA | Import Alert 66-40 | November 30, 2017 | Not Available | ||
| Changzhou Anyuan Import & Export | China | FDA | Import Alert 66-40 | August 11, 2017 | Not Available | ||
| Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. | China | FDA | Import Alert 66-40 | August 21, 2017 | Not Available | ||
| Guangzhou Baiyunshan Pharmaceutical Co., Ltd. | China | FDA | Import Alert 66-40 | October 25, 2017 | Not Available | ||
| Hangzhou Facecare Cosmetics Co., Ltd. | China | FDA | Import Alert 66-40 | September 14, 2017 | Not Available | ||
| Hubei Danao Pharmaceutical Co., Ltd. | China | FDA | Import Alert 66-40 | November 1, 2017 | Not Available | ||
| Hunan Norchem Pharmaceutical Co. Ltd. | China | FDA | Import Alert 66-40 | October 18, 2017 | Not Available | ||
| Jiangsu YongAn Pharmaceutical Co., Ltd | China | FDA | Import Alert 66-40 | November 27, 2017 | Not Available | ||
| Shandong Vianor Biotech Co., Ltd. | China | FDA | Import Alert 66-40 | August 22, 2017 | Not Available | ||
| Shanghai Weierya Daily Chemicals Factory | China | FDA | Import Alert 66-40 | September 14, 2017 | Not Available | ||
| Shanwei Honghui Daily Appliance Co., Ltd. | China | FDA | Import Alert 66-40 | November 2, 2017 | Not Available | ||
| Shenzhen Senton Science & Technology Co.,Ltd. | China | FDA | Import Alert 66-40 | November 21, 2017 | Not Available | ||
| Wuhan Chinese Moxibustion Technology Dev. Co., Ltd. | China | FDA | Import Alert 66-40 | October 19, 2017 | Not Available | ||
| Yicheng Chemical Corp. | China | FDA | Import Alert 66-40 | August 11, 2017 | Not Available | ||
| Fleming Laboratories Ltd. | India | FDA | Import Alert 66-40 | October 20, 2017 | Not Available | ||
| Kim Chemicals Private Ltd. | India | FDA | Import Alert 66-40 | August 21, 2017 | Not Available | ||
| Mahendra Chemicals | India | FDA | Import Alert 66-40 | August 25, 2017 | Not Available | ||
| Malladi Drugs & Pharmaceuticals Ltd. | India | FDA | Import Alert 66-40 | December 13, 2017 | Not Available | ||
| BBCOS srl | Italy | FDA | Import Alert 66-40 | November 27, 2017 | Not Available | ||
| Daito Kasei Kogyo Co Ltd | Japan | FDA | Import Alert 66-40 | October 25, 2017 | Not Available | ||
| Amaros Co., Ltd | Korea | FDA | Import Alert 66-40 | August 23, 2017 | Not Available | ||
| Seindni Co., Ltd. | Korea | FDA | Import Alert 66-40 | August 23, 2017 | Not Available | ||
| Prosana Distribuciones S.A. de C.V. | Mexico | FDA | Import Alert 66-40 | July 12, 2017 | Not Available | ||
| Casmara Cosmetics, S.A. | Spain | FDA | Import Alert 66-40 | October 12, 2017 | Not Available | ||
| International Cosmetics Limited | Trinidad & Tobago | FDA | Import Alert 66-40 | November 28, 2017 | Not Available | ||
| Chongqing Succeway Pharmaceutical Co., Ltd | China | EDQM | Non-Compliance | July 20, 2017 | June 24, 2017 | Active Pharmaceutical Ingredients | Yes |
| Biocon Limited | India | EDQM | Non-Compliance | July 5, 2017 | March 17, 2017 | Finished Pharmaceuticals | |
| Kores (India) Limited | India | EDQM | Non-Compliance | May 9, 2017 | March 4, 2017 | Active Pharmaceutical Ingredients | Yes |
| Nova Dfl Industrie E Commercio Sa | Brazil | EDQM | Non-Compliance | April 24, 2017 | February 17, 2017 | Finished Pharmaceuticals | Yes |
| Euro Far Alergi, S. L. | Spain | EDQM | Non-Compliance | January 27, 2017 | January 20, 2017 | Finished Pharmaceuticals | |
| Antibioticos Do Brasil Ltda | Brazil | EDQM | Non-Compliance | January 5, 2017 | December 16, 2016 | Finished Pharmaceuticals | |
| Pharma International Company | Jordan | EDQM | Non-Compliance | March 15, 2017 | October 13, 2016 | Finished Pharmaceuticals | |
| Gauke Healthcare Co., Ltd | China | FDA | Import Alert 99-32 | March 28, 2017 | Not Available | ||
| Ultratech India Ltd | India | FDA | Import Alert 99-32 | February 13, 2017 | Not Available | ||
| Vikshara Trading & Investments | India | FDA | Import Alert 99-32 | February 9, 2017 | Not Available | ||
| Jiangxi Hengxiang Pharmaceutical Technology Co. Ltd | China | FDA | Import Alert 99-32 | April 27, 2017 | Not Available | ||
| Bicooya Cosmetics Limited | China | FDA | Import Alert 66-40 | June 29, 2017 | Not Available | ||
| Homeocan | Canada | FDA | Import Alert 66-40 | May 3, 2017 | Not Available | ||
| Cellex-C International Inc | Canada | FDA | Import Alert 66-40 | June 2, 2017 | Not Available | ||
| Homeolab USA Inc. | Canada | FDA | Import Alert 66-40 | May 3, 2017 | Not Available | ||
| CR Zizhu Pharmaceutical Co Ltd | China | FDA | Import Alert 66-40 | March 8, 2017 | Not Available | ||
| Changzhou Jintan Qianyao Pharmaceutical Raw Materials | China | FDA | Import Alert 66-40 | May 4, 2017 | Not Available | ||
| Foshan Flying Medical Products Co., Ltd. | China | FDA | Import Alert 66-40 | May 23, 2017 | Not Available | ||
| Jiangmen Nowadays Daily Goods Co., Ltd | China | FDA | Import Alert 66-40 | June 7, 2017 | Not Available | ||
| Lumis Global Pharmaceuticals | China | FDA | Import Alert 66-40 | February 15, 2017 | Not Available | ||
| Qinhuangdao Zizhu Pharmaceutical | China | FDA | Import Alert 66-40 | March 8, 2017 | Not Available | ||
| Sal Pharma | India | FDA | Import Alert 66-40 | February 15, 2017 | Not Available | ||
| Vikshara Trading & Investments | India | FDA | Import Alert 66-40 | February 8, 2017 | Not Available | ||
| Firson Co., Ltd. | Korea | FDA | Import Alert 66-40 | May 11, 2017 | Not Available | ||
| Biocon Limited | India | FDA | 483 | June 2, 2017 | May 25 to June 1 & June 3, 2017 | API & FDF | |
| Intas Pharmaceuticals | India | FDA | 483 | May 10, 2017 | April 26 to May 10, 2017 | Active Pharmaceutical Ingredients | |
| Zhejiang Bangli Medical Products | China | FDA | 483 | August 17, 2016 | August 16 to 17, 2016 | Finished Pharmaceuticals | |
| Lupin Limited | India | FDA | 483 | June 16, 2017 | June 12 to 16, 2017 | Finished Pharmaceuticals | |
| Dr. Reddy's Laboratories | India | FDA | 483 | June 16, 2017 | June 12 to 16, 2017 | Finished Pharmaceuticals | |
| Strides Shasun Limited | India | FDA | 483 | May 26, 2017 | May 22 to 26, 2017 | Finished Pharmaceuticals | |
| Lupin Limited | India | FDA | 483 | May 19, 2017 | May 8 to 19, 2017 | Finished Pharmaceuticals | |
| Sekisui Medical | Japan | FDA | 483 | June 17, 2016 | June 13 to 17, 2016 | Active Pharmaceutical Ingredients | |
| Torrent Pharmaceuticals Limited | India | FDA | 483 | April 28, 2017 | April 17 to 28, 2017 | API & FDF | |
| Badrivishal Chemicals & Pharmaceuticals | India | FDA | 483 | August 19, 2016 | August 16 to 19, 2016 | Active Pharmaceutical Ingredients | |
| Cosma SpA | Italy | FDA | 483 | January 15, 2016 | January 11 to 15, 2016 | Active Pharmaceutical Ingredients | |
| Aurobindo Pharma | India | FDA | 483 | July 1, 2016 | June 27 to July 1, 2016 | Active Pharmaceutical Ingredients | |
| Biocon Limited | India | FDA | 483 | April 7, 2017 | March 27 to April 7, 2017 | API & FDF | |
| Aurobindo Pharma | India | FDA | 483 | April 28, 2017 | April 20 to 28, 2017 | Finished Pharmaceuticals | |
| Dr. Reddy's Laboratories | India | FDA | 483 | April 28, 2017 | April 19 to 28, 2017 | Finished Pharmaceuticals | |
| Aurobindo Pharma | India | FDA | 483 | April 18, 2017 | April 10 to 18, 2017 | Finished Pharmaceuticals | |
| Lupin Limited | India | FDA | 483 | April 7, 2017 | March 27 to April 7, 2017 | Finished Pharmaceuticals | |
| Dr. Reddy's Laboratories | India | FDA | 483 | April 4, 2017 | March 27 to April 4, 2017 | Active Pharmaceutical Ingredients | |
| Marksans Pharma Ltd. | India | FDA | 483 | April 7, 2017 | April 3 to 7, 2017 | Finished Pharmaceuticals | |
| Sun Pharmaceutical Industries Ltd. | India | FDA | 483 | April 13, 2017 | April 6 to 13, 2017 | Finished Pharmaceuticals | |
| Alkem Laboratories Limited | India | FDA | 483 | March 10, 2017 | March 2 to 10, 2017 | Finished Pharmaceuticals | |
| Dr. Reddy's Laboratories | India | FDA | 483 | March 8, 2017 | February 27 to February 28 & March 1, March 3, March 6, March 8, 2017 | Finished Pharmaceuticals | |
| Cadila Healthcare Limited | India | FDA | 483 | March 1, 2017 | February 21 to March 1, 2017 | Finished Pharmaceuticals | |
| Dr. Reddy's Laboratories | India | FDA | 483 | February 21, 2017 | February 13 to February 17 & February 20 to 21, 2017 | Active Pharmaceutical Ingredients | |
| Natco Pharma Limited | India | FDA | 483 | January 24, 2017 | January 16 to 24, 2017 | Finished Pharmaceuticals | |
| CP Pharmaceuticals | United Kingdom | FDA | 483 | October 13, 2015 | October 5 to 13, 2015 | Finished Pharmaceuticals | |
| Wockhardt Limited | India | FDA | 483 | December 15, 2015 | December 7 to 15, 2015 | Active Pharmaceutical Ingredients | |
| Hetero Labs Limited | India | FDA | 483 | December 16, 2016 | December 7 to 16, 2016 | Finished Pharmaceuticals | |
| Granules | India | FDA | 483 | December 9, 2016 | December 5 to 9, 2016 | Active Pharmaceutical Ingredients | |
| Aurobindo Pharma | India | FDA | 483 | October 25, 2016 | October 17 to 25, 2016 | Active Pharmaceutical Ingredients | |
| Yunnan Baiyao Group Co., Ltd. | China | FDA | Import Alert 99-32 | December 28, 2017 | Not Available | ||
| Alcon Biosciences Pvt Ltd | India | FDA | Import Alert 99-32 | September 21, 2017 | Not Available | ||
| Sungwon Cosmetic Inc | Korea | FDA | Import Alert 99-32 | September 22, 2017 | Not Available | ||
| Monkey Holding Peach Brand Company Ltd. | Thailand | FDA | Import Alert 99-32 | November 21, 2017 | Not Available | ||
| Nox Bellcow Cosmetics Co. Ltd. | China | FDA | Import Alert 66-40 | December 27, 2017 | Not Available | ||
| Zhejiang Ludao Technology Co., Ltd | China | FDA | Import Alert 66-40 | December 28, 2017 | Not Available | ||
| Nowcos | Korea | FDA | Import Alert 66-40 | December 27, 2017 | Not Available | ||
| Nowcos | Korea | FDA | Import Alert 66-40 | December 27, 2017 | Not Available | ||
| Nowcos | Korea | FDA | Import Alert 66-40 | December 27, 2017 | Not Available | ||
| Nowcos | Korea | FDA | Import Alert 66-40 | December 27, 2017 | Not Available | ||
| Nowcos | Korea | FDA | Import Alert 66-40 | December 27, 2017 | Not Available |
