| Celltrion Inc. | South Korea | FDA | EIR | 02-Jun-17 | May 22 to June 02, 2017 | FDF/API |
| Dr. Reddy's Laboratories | India | FDA | EIR | 08-Mar-17 | February 27 to March 08, 2018 | FDF |
| Akorn AG | Switzerland | FDA | Form 483 | 25-May-18 | May 17 to 25, 2016 | FDF |
| Akorn AG | Switzerland | FDA | Form 483 | 12-Dec-17 | December 4 to 12, 2017 | FDF |
| Alembic Pharmaceuticals Ltd. | India | FDA | Form 483 | 20-Mar-18 | March 12 to 20, 2018 | FDF |
| Alkem Laboratories Ltd. | India | FDA | Form 483 | 27-Mar-18 | March 19 to 27, 2018 | FDF |
| Aurobindo Pharma Ltd. | India | FDA | Form 483 | 20-Feb-18 | February 12 to 20, 2018 | FDF |
| Auronext Pharma | India | FDA | Form 483 | 06-Mar-18 | February 26 to March 06, 2018 | FDF |
| Bayer AG Pharma | Germany | FDA | Form 483 | 20-Jan-17 | January 12 to 20, 2017 | API/FDF |
| Biocon Ltd. | India | FDA | Form 483 | 01-May-18 | April 23 to May 01, 2018 | API/FDF |
| Biocon Sdn Bhd | Malaysia | FDA | Form 483 | 15-Feb-18 | February 06 to 15, 2018 | FDF |
| Celltrion Inc. | South Korea | FDA | Form 483 | 02-Jun-17 | May 22-26 and May 29 to June 2, 2017 | API/FDF |
| Cipla Ltd. | India | FDA | Form 483 | 13-Apr-18 | April 02 to 13, 2018 | FDF |
| Cipla Ltd. | India | FDA | Form 483 | 25-Jan-18 | January 22 to 25, 2018 | FDF |
| Daewoong Pharmaceutical Co., Ltd. | South Korea | FDA | Form 483 | 17-Nov-17 | November 08 to 17, 2017 | API/FDF |
| Dr. Reddy's Laboratories | India | FDA | Form 483 | 09-Mar-18 | March 05 to 09, 2018 | API |
| Galaxy Surfactants Ltd. | India | FDA | Form 483 | 30-Mar-18 | March 26 to 30, 2018 | API/IN |
| Galaxy Surfactants Ltd. | India | FDA | Form 483 | 23-Mar-18 | March 19 to 23, 2018 | API |
| Glenmark Pharmaceuticals Ltd. | India | FDA | Form 483 | 24-May-18 | May 14 to 24, 2018 | FDF |
| Hetero Drugs Ltd. | United States | FDA | Form 483 | 02-Mar-18 | February 26 to March 2, 2018 | API |
| Hospira Healthcare India | India | FDA | Form 483 | 03-Apr-18 | March 27 to April 3, 2018 | API/FDF |
| Indoco Remedies | India | FDA | Form 483 | 19-Jan-18 | January 15 to 19, 2018 | FDF |
| Mylan Laboratories Ltd. | India | FDA | Form 483 | 14-Sep-16 | September 5 to 14, 2016 | FDF |
| Shilpa Medicare | India | FDA | Form 483 | 19-Jan-18 | January 16 to 19, 2018 | API/IN |
| Sun Pharmaceutical Industries Ltd. | India | FDA | Form 483 | 23-Feb-18 | February 12 to 23, 2018 | FDF |
| Suven Life Sciences Ltd. | India | FDA | Form 483 | 15-Feb-18 | February 05 to 15, 2018 | API/FDF/IN |
| Apotex Research Private Ltd. | India | FDA | Import Alert 66-40 | 12-Apr-18 | Not Available | Not Available |
| Beijing Rimeng Biological Technology Co., Ltd. | China | FDA | Import Alert 66-40 | 24-Jan-18 | Not Available | Not Available |
| BR SAS | France | FDA | Import Alert 66-40 | 17-Jan-18 | Not Available | Not Available |
| Cosmecca Korea Co., Ltd. | South Korea | FDA | Import Alert 66-40 | 08-Jan-18 | Not Available | Not Available |
| Europharma Concepts Ltd. | Ireland | FDA | Import Alert 66-40 | 22-Feb-18 | Not Available | Not Available |
| Foshan Jinxiong Technology Co., Ltd. | China | FDA | Import Alert 66-40 | 14-Feb-18 | Not Available | Not Available |
| Goran Pharma Pvt Ltd. | India | FDA | Import Alert 66-40 | 05-Mar-18 | Not Available | Not Available |
| Hanbul Cosmetics Co., Ltd. | South Korea | FDA | Import Alert 66-40 | 08-Mar-18 | Not Available | Not Available |
| Hanlim Pharm Co., Ltd. | South Korea | FDA | Import Alert 66-40 | 03-May-18 | Not Available | Not Available |
| Health Biotech Ltd. (Chandigarh) | India | FDA | Import Alert 66-40 | 03-Apr-18 | Not Available | Not Available |
| Health Biotech Ltd. (Himachal) | India | FDA | Import Alert 66-40 | 03-Apr-18 | Not Available | Not Available |
| Henan Lihua Pharmaceutical Co., Ltd. | China | FDA | Import Alert 66-40 | 29-Mar-18 | Not Available | Not Available |
| Hubei Goto Healthcare Co., Ltd. | China | FDA | Import Alert 66-40 | 10-Jan-18 | Not Available | Not Available |
| Jalco Cosmetics Pty Ltd. | Australia | FDA | Import Alert 66-40 | 08-Mar-18 | Not Available | Not Available |
| Jilin Shulan Synthetic Pharmaceutical Co., Ltd. | China | FDA | Import Alert 66-40 | 01-Mar-18 | Not Available | Not Available |
| JT Cosmetics & Chemicals Pvt Ltd. | India | FDA | Import Alert 66-40 | 11-Jun-18 | Not Available | Not Available |
| Kopalle Pharma Chemical Pvt Ltd. | India | FDA | Import Alert 66-40 | 22-Jun-18 | Not Available | Not Available |
| Labocont Industrial SRL | Dominican Republic | FDA | Import Alert 66-40 | 08-Feb-18 | Not Available | Not Available |
| Lernapharm (Loris) Inc. | Canada | FDA | Import Alert 66-40 | 24-Apr-18 | Not Available | Not Available |
| Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. | China | FDA | Import Alert 66-40 | 08-Feb-18 | Not Available | Not Available |
| Luen Wah (HK) Medicine Ltd. | Hong Kong | FDA | Import Alert 66-40 | 18-Jan-18 | Not Available | Not Available |
| Nan San (HK) Pharmaceutical Factory Ltd. | Hong Kong | FDA | Import Alert 66-40 | 08-Jan-18 | Not Available | Not Available |
| Polaroisin International Co., Ltd. | Taiwan | FDA | Import Alert 66-40 | 08-Jan-18 | Not Available | Not Available |
| Reine Lifescience | India | FDA | Import Alert 66-40 | 30-Mar-18 | Not Available | Not Available |
| Sichuan Friendly Pharmaceutical Co., Ltd. | China | FDA | Import Alert 66-40 | 22-Mar-18 | Not Available | Not Available |
| Vista Pharmaceuticals Ltd. | India | FDA | Import Alert 66-40 | 22-May-18 | Not Available | Not Available |
| Wong Lap Kwong Medicine Company Ltd. | Hong Kong | FDA | Import Alert 66-40 | 08-Jan-18 | Not Available | Not Available |
| Yicheng Goto Pharmaceuticals Co., Ltd. | China | FDA | Import Alert 66-40 | 10-Jan-18 | Not Available | Not Available |
| Vipor Chemicals Private Ltd. | India | FDA | Import Alert 66-40 | 11-Jul-18 | Not Available | Not Available |
| Jilin Shulan Synthetic Pharmaceutical Co. Ltd. | China | FDA | Import Alert 66-40 | 01-Mar-18 | Not Available | Not Available |
| Bill Beauty and Health Products Ltd. | Canada | FDA | Import Alert 66-40 | 24-Jul-18 | Not Available | Not Available |
| Hangzhou Karic Commodities Co., Ltd. | China | FDA | Import Alert 99-32 | 16-Jul-18 | Not Available | Not Available |
| DHP Korea Co., Ltd. | South Korea | FDA | Import Alert 99-32 | 24-Apr-18 | Not Available | Not Available |
| Guangzhou Topwork Chemical Co., Ltd. | China | FDA | Import Alert 99-32 | 06-Jun-18 | Not Available | Not Available |
| Yuyao Chengze Medical Supplies Factory | China | FDA | Import Alert 99-32 | 04-Apr-18 | Not Available | Not Available |
| Lincoln Pharmaceuticals Ltd. | India | FDA | Import Alert 99-32 | 17-Apr-18 | Not Available | Not Available |
| Tongzhou Ruihong Medical Products Factory | China | FDA | Import Alert 99-32 | 15-Feb-18 | Not Available | Not Available |
| Yangzhou Holyshine Industrial Co., Ltd. | China | FDA | Import Alert 99-32 | 17-Jul-18 | Not Available | Not Available |
| Tamnamo Co., Ltd. | South Korea | FDA | Import Alert 99-32 | 24-Jul-18 | Not Available | Not Available |
| Laboratorio Jaer, S.A. | Spain | EDQM | Non-Compliance | 21-May-18 | 27-Apr-18 | FDF |
| Lampugnani Farmaceutici SPA | Italy | EDQM | Non-Compliance | 24-May-18 | 18-Jul-18 | API |
| Dhanuka Laboratories Ltd. | India | EDQM | Non-Compliance | 19-Jun-18 | 28-Mar-18 | API |
| Savior Lifetec Corporation | Taiwan | EDQM | Non-Compliance | 15-May-18 | 15-Mar-18 | FDF |
| Indoco Remedies Ltd. | India | EDQM | Non-Compliance | 23-Apr-18 | 14-Mar-18 | FDF |
| Theon Pharmaceuticals Ltd. | India | EDQM | Non-Compliance | 23-Apr-18 | 11-Mar-18 | FDF |
| Alchymars ICM SM Private Ltd. | India | FDA | Warning Letter | 16-Feb-18 | September 11 to 15, 2017 | API/FDF |
| Beauty Manufacturing Solutions Corp. | United States | FDA | Warning Letter | 12-Jan-18 | June 19 to 30, 2017 | FDF |
| BR SAS | France | FDA | Warning Letter | 08-Jun-18 | September 18 to 22, 2017 | FDF |
| Casmara Cosmetics, S.A. | Spain | FDA | Warning Letter | 12-Feb-18 | May 29 to 31, 2017 | FDF |
| Celltrion Inc. | South Korea | FDA | Warning Letter | 26-Jan-18 | May 22 to June 2, 2017 | FDF |
| Cerno Pharmaceutical | United States | FDA | Warning Letter | 15-May-18 | November 13 to 17, 2017 | FDF |
| Clover Custom Blending LLC | United States | FDA | Warning Letter | 28-Feb-18 | May 15 to 17, 2017 | FDF |
| Cosmecca Korea Co., Ltd. | South Korea | FDA | Warning Letter | 02-Feb-18 | September 18 to 22, 2017 | FDF |
| Daito Kasei Kogyo Co Ltd. | Japan | FDA | Warning Letter | 18-Jan-18 | July 18 to 21, 2017 | API |
| Degasa S.A. De C.V. | México | FDA | Warning Letter | 18-Apr-18 | September 4 to 8, 2017 | FDF |
| Diamond Wipes International, Inc. | United States | FDA | Warning Letter | 07-Mar-18 | May 8–17, 2017 | FDF |
| Ei LLC | United States | FDA | Warning Letter | 16-Apr-18 | October 2 to 6, 2017 | FDF |
| Europharma Concepts Ltd. | Ireland | FDA | Warning Letter | 16-May-18 | October 31 to November 3, 2017 | FDF |
| Foshan Jinxiong Technology Co., Ltd. | China | FDA | Warning Letter | 26-Jun-18 | August 15–18, 2017 | FDF |
| Goran Pharma Pvt Ltd. | India | FDA | Warning Letter | 24-Apr-18 | November 13 to 15, 2017 | FDF |
| Hanbul Cosmetics Co., Ltd. | South Korea | FDA | Warning Letter | 29-Mar-18 | November 27 to December 1, 2017 | FDF |
| Henan Lihua Pharmaceutical Co., Ltd. | China | FDA | Warning Letter | 12-Jun-18 | December 11 to 14, 2017 | API |
| Hunan Norchem Pharmaceutical Co., Ltd. | China | FDA | Warning Letter | 09-Jan-18 | July 24 to 28, 2017 | API |
| IDT Australia Ltd. | Australia | FDA | Warning Letter | 23-May-18 | December 4 to 8, 2017 | API |
| Jalco Cosmetics Pty Ltd. | Australia | FDA | Warning Letter | 18-May-18 | December 11 to 13, 2017 | FDF |
| Jilin Shulan Synthetic Pharmaceutical Co., Ltd. | China | FDA | Warning Letter | 14-May-18 | November 7 to 10, 2017 | API |
| Keshava Organics Pvt. Ltd. | India | FDA | Warning Letter | 15-Mar-18 | May 25 to 31, 2017 | API |
| Kolmar Korea Co., Ltd. | South Korea | FDA | Warning Letter | 18-May-18 | September 25 to 28, 2017 | FDF |
| Labocont Industrial SRL | Dominican Republic | FDA | Warning Letter | 09-Mar-18 | June 5 to 9, 2017 | FDF |
| Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. | China | FDA | Warning Letter | 19-Apr-18 | October 16 to 20, 2017 | API |
| Luen Wah (HK) Medicine Ltd. | Hong Kong | FDA | Warning Letter | 06-Apr-18 | September 25 to 28, 2017 | FDF |
| Malladi Drugs & Pharmaceuticals Ltd. | India | FDA | Warning Letter | 09-Mar-18 | September 4 to 8, 2017 | API |
| McCallum Manufacturing Ltd. | United Kingdom | FDA | Warning Letter | 09-Apr-18 | July 24 to 26, 2017 | FDF |
| Nan San (HK) Pharmaceutical Factory Ltd. | Hong Kong | FDA | Warning Letter | 23-Feb-18 | September 25 to 29, 2017 | FDF |
| Nowcos Co., Ltd. | South Korea | FDA | Warning Letter | 14-Feb-18 | July 31 to August 4, 2017 | FDF |
| Nox Bellcow Cosmetics Co., Ltd. | China | FDA | Warning Letter | 09-May-18 | September 18 to 22, 2017 | FDF |
| Phase 4 Pharmaceutical LLC | United States | FDA | Warning Letter | 18-Apr-18 | April 26 to May 2, 2017 | FDF |
| Polaroisin International Co., Ltd. | Taiwan | FDA | Warning Letter | 25-Jan-18 | September 11 to 15, 2017 | FDF |
| Quali Controle & Qual-Controle-C.E.Bac | France | FDA | Warning Letter | 05-Mar-18 | September 14 to 15, 2017 | FDF |
| Reine Lifescience | India | FDA | Warning Letter | 09-May-18 | October 30 to November 3, 2017 | API |
| Shanghai Weierya Daily Chemicals Factory | China | FDA | Warning Letter | 07-Feb-18 | April 10 to 14, 2017 | FDF |
| Sichuan Friendly Pharmaceutical Co., Ltd. | China | FDA | Warning Letter | 22-Jun-18 | October 23 to 27, 2017 | API |
| Taiwan Biotech Co., Ltd. | Taiwan | FDA | Warning Letter | 31-May-18 | September 1 to 11, 2017 | FDF |
| Tris Pharma Inc. | United States | FDA | Warning Letter | 26-Mar-18 | February 14 to March 20, 2017 | FDF |
| Wong Lap Kwong Medicine Company Ltd. | Hong Kong | FDA | Warning Letter | 11-Jan-18 | September 18 to 22, 2017 | FDF |
| Yicheng Chemical Corp. | China | FDA | Warning Letter | 02-Jan-18 | July 17 to 21, 2017 | API |
| Zhejiang Ludao Technology Co., Ltd. | China | FDA | Warning Letter | 23-Feb-18 | August 14 to 18, 2017 | FDF |
| Zhuhai United Laboratories Co., Ltd. | China | FDA | Warning Letter | 27-Jun-18 | September 11 - 15, 2017. | API |
| Claris Injectables Ltd. | India | FDA | Warning Letter | 05-Jul-18 | July 27, 2017 to August 4, 2017 | FDF |
