Company NameCountryRegulatorRegulatory ActionIssue DateDate of InspectionFacility Type
Celltrion Inc.South KoreaFDAEIR02-Jun-17May 22 to June 02, 2017FDF/API
Dr. Reddy's LaboratoriesIndiaFDAEIR08-Mar-17February 27 to March 08, 2018FDF
Akorn AGSwitzerlandFDAForm 48325-May-18May 17 to 25, 2016FDF
Akorn AGSwitzerlandFDAForm 48312-Dec-17 December 4 to 12, 2017FDF
Alembic Pharmaceuticals Ltd.IndiaFDAForm 48320-Mar-18March 12 to 20, 2018FDF
Alkem Laboratories Ltd.IndiaFDAForm 48327-Mar-18March 19 to 27, 2018FDF
Aurobindo Pharma Ltd.IndiaFDAForm 48320-Feb-18February 12 to 20, 2018FDF
Auronext PharmaIndiaFDAForm 48306-Mar-18February 26 to March 06, 2018FDF
Bayer AG PharmaGermanyFDAForm 48320-Jan-17January 12 to 20, 2017API/FDF
Biocon Ltd.IndiaFDAForm 48301-May-18April 23 to May 01, 2018API/FDF
Biocon Sdn BhdMalaysiaFDAForm 48315-Feb-18February 06 to 15, 2018FDF
Celltrion Inc.South KoreaFDAForm 48302-Jun-17May 22-26 and May 29 to June 2, 2017API/FDF
Cipla Ltd.IndiaFDAForm 48313-Apr-18April 02 to 13, 2018FDF
Cipla Ltd.IndiaFDAForm 48325-Jan-18January 22 to 25, 2018FDF
Daewoong Pharmaceutical Co., Ltd.South KoreaFDAForm 48317-Nov-17November 08 to 17, 2017API/FDF
Dr. Reddy's LaboratoriesIndiaFDAForm 48309-Mar-18March 05 to 09, 2018API
Galaxy Surfactants Ltd.IndiaFDAForm 48330-Mar-18March 26 to 30, 2018API/IN
Galaxy Surfactants Ltd.IndiaFDAForm 48323-Mar-18March 19 to 23, 2018API
Glenmark Pharmaceuticals Ltd.IndiaFDAForm 48324-May-18May 14 to 24, 2018FDF
Hetero Drugs Ltd.United StatesFDAForm 48302-Mar-18February 26 to March 2, 2018API
Hospira Healthcare IndiaIndiaFDAForm 48303-Apr-18March 27 to April 3, 2018API/FDF
Indoco RemediesIndiaFDAForm 48319-Jan-18January 15 to 19, 2018FDF
Mylan Laboratories Ltd.IndiaFDAForm 48314-Sep-16September 5 to 14, 2016FDF
Shilpa MedicareIndiaFDAForm 48319-Jan-18January 16 to 19, 2018API/IN
Sun Pharmaceutical Industries Ltd.IndiaFDAForm 48323-Feb-18February 12 to 23, 2018FDF
Suven Life Sciences Ltd.IndiaFDAForm 48315-Feb-18February 05 to 15, 2018API/FDF/IN
Apotex Research Private Ltd.IndiaFDAImport Alert 66-4012-Apr-18Not AvailableNot Available
Beijing Rimeng Biological Technology Co., Ltd.ChinaFDAImport Alert 66-4024-Jan-18Not AvailableNot Available
BR SASFranceFDAImport Alert 66-4017-Jan-18Not AvailableNot Available
Cosmecca Korea Co., Ltd.South KoreaFDAImport Alert 66-4008-Jan-18Not AvailableNot Available
Europharma Concepts Ltd.IrelandFDAImport Alert 66-4022-Feb-18Not AvailableNot Available
Foshan Jinxiong Technology Co., Ltd.ChinaFDAImport Alert 66-4014-Feb-18Not AvailableNot Available
Goran Pharma Pvt Ltd.IndiaFDAImport Alert 66-4005-Mar-18Not AvailableNot Available
Hanbul Cosmetics Co., Ltd.South KoreaFDAImport Alert 66-4008-Mar-18Not AvailableNot Available
Hanlim Pharm Co., Ltd.South KoreaFDAImport Alert 66-4003-May-18Not AvailableNot Available
Health Biotech Ltd. (Chandigarh)IndiaFDAImport Alert 66-4003-Apr-18Not AvailableNot Available
Health Biotech Ltd. (Himachal)IndiaFDAImport Alert 66-4003-Apr-18Not AvailableNot Available
Henan Lihua Pharmaceutical Co., Ltd.ChinaFDAImport Alert 66-4029-Mar-18Not AvailableNot Available
Hubei Goto Healthcare Co., Ltd.ChinaFDAImport Alert 66-4010-Jan-18Not AvailableNot Available
Jalco Cosmetics Pty Ltd.AustraliaFDAImport Alert 66-4008-Mar-18Not AvailableNot Available
Jilin Shulan Synthetic Pharmaceutical Co., Ltd.ChinaFDAImport Alert 66-4001-Mar-18Not AvailableNot Available
JT Cosmetics & Chemicals Pvt Ltd.IndiaFDAImport Alert 66-4011-Jun-18Not AvailableNot Available
Kopalle Pharma Chemical Pvt Ltd.IndiaFDAImport Alert 66-4022-Jun-18Not AvailableNot Available
Labocont Industrial SRLDominican RepublicFDAImport Alert 66-4008-Feb-18Not AvailableNot Available
Lernapharm (Loris) Inc.CanadaFDAImport Alert 66-4024-Apr-18Not AvailableNot Available
Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd.ChinaFDAImport Alert 66-4008-Feb-18Not AvailableNot Available
Luen Wah (HK) Medicine Ltd.Hong KongFDAImport Alert 66-4018-Jan-18Not AvailableNot Available
Nan San (HK) Pharmaceutical Factory Ltd.Hong KongFDAImport Alert 66-4008-Jan-18Not AvailableNot Available
Polaroisin International Co., Ltd.TaiwanFDAImport Alert 66-4008-Jan-18Not AvailableNot Available
Reine LifescienceIndiaFDAImport Alert 66-4030-Mar-18Not AvailableNot Available
Sichuan Friendly Pharmaceutical Co., Ltd.ChinaFDAImport Alert 66-4022-Mar-18Not AvailableNot Available
Vista Pharmaceuticals Ltd.IndiaFDAImport Alert 66-4022-May-18Not AvailableNot Available
Wong Lap Kwong Medicine Company Ltd.Hong KongFDAImport Alert 66-4008-Jan-18Not AvailableNot Available
Yicheng Goto Pharmaceuticals Co., Ltd.ChinaFDAImport Alert 66-4010-Jan-18Not AvailableNot Available
Vipor Chemicals Private Ltd.IndiaFDAImport Alert 66-4011-Jul-18Not AvailableNot Available
Jilin Shulan Synthetic Pharmaceutical Co. Ltd.ChinaFDAImport Alert 66-4001-Mar-18Not AvailableNot Available
Bill Beauty and Health Products Ltd.CanadaFDAImport Alert 66-4024-Jul-18Not AvailableNot Available
Hangzhou Karic Commodities Co., Ltd.ChinaFDAImport Alert 99-3216-Jul-18Not AvailableNot Available
DHP Korea Co., Ltd.South KoreaFDAImport Alert 99-3224-Apr-18Not AvailableNot Available
Guangzhou Topwork Chemical Co., Ltd.ChinaFDAImport Alert 99-3206-Jun-18Not AvailableNot Available
Yuyao Chengze Medical Supplies FactoryChinaFDAImport Alert 99-3204-Apr-18Not AvailableNot Available
Lincoln Pharmaceuticals Ltd.IndiaFDAImport Alert 99-3217-Apr-18Not AvailableNot Available
Tongzhou Ruihong Medical Products FactoryChinaFDAImport Alert 99-3215-Feb-18Not AvailableNot Available
Yangzhou Holyshine Industrial Co., Ltd.ChinaFDAImport Alert 99-3217-Jul-18Not AvailableNot Available
Tamnamo Co., Ltd.South KoreaFDAImport Alert 99-3224-Jul-18Not AvailableNot Available
Laboratorio Jaer, S.A.SpainEDQMNon-Compliance21-May-1827-Apr-18FDF
Lampugnani Farmaceutici SPAItalyEDQMNon-Compliance24-May-1818-Jul-18API
Dhanuka Laboratories Ltd.IndiaEDQMNon-Compliance19-Jun-1828-Mar-18API
Savior Lifetec CorporationTaiwanEDQMNon-Compliance15-May-1815-Mar-18FDF
Indoco Remedies Ltd.IndiaEDQMNon-Compliance23-Apr-1814-Mar-18FDF
Theon Pharmaceuticals Ltd.IndiaEDQMNon-Compliance23-Apr-1811-Mar-18FDF
Alchymars ICM SM Private Ltd.IndiaFDAWarning Letter16-Feb-18September 11 to 15, 2017API/FDF
Beauty Manufacturing Solutions Corp.United StatesFDAWarning Letter12-Jan-18June 19 to 30, 2017FDF
BR SASFranceFDAWarning Letter08-Jun-18September 18 to 22, 2017FDF
Casmara Cosmetics, S.A.SpainFDAWarning Letter12-Feb-18 May 29 to 31, 2017FDF
Celltrion Inc.South KoreaFDAWarning Letter26-Jan-18May 22 to June 2, 2017FDF
Cerno PharmaceuticalUnited StatesFDAWarning Letter15-May-18November 13 to 17, 2017FDF
Clover Custom Blending LLCUnited StatesFDAWarning Letter28-Feb-18May 15 to 17, 2017FDF
Cosmecca Korea Co., Ltd.South KoreaFDAWarning Letter02-Feb-18September 18 to 22, 2017FDF
Daito Kasei Kogyo Co Ltd.JapanFDAWarning Letter18-Jan-18July 18 to 21, 2017API
Degasa S.A. De C.V.MéxicoFDAWarning Letter18-Apr-18September 4 to 8, 2017FDF
Diamond Wipes International, Inc.United StatesFDAWarning Letter07-Mar-18 May 8–17, 2017FDF
Ei LLCUnited StatesFDAWarning Letter16-Apr-18October 2 to 6, 2017FDF
Europharma Concepts Ltd.IrelandFDAWarning Letter16-May-18October 31 to November 3, 2017FDF
Foshan Jinxiong Technology Co., Ltd.ChinaFDAWarning Letter26-Jun-18August 15–18, 2017FDF
Goran Pharma Pvt Ltd.IndiaFDAWarning Letter24-Apr-18November 13 to 15, 2017FDF
Hanbul Cosmetics Co., Ltd.South KoreaFDAWarning Letter29-Mar-18November 27 to December 1, 2017FDF
Henan Lihua Pharmaceutical Co., Ltd.ChinaFDAWarning Letter12-Jun-18December 11 to 14, 2017API
Hunan Norchem Pharmaceutical Co., Ltd.ChinaFDAWarning Letter09-Jan-18July 24 to 28, 2017API
IDT Australia Ltd.AustraliaFDAWarning Letter23-May-18December 4 to 8, 2017API
Jalco Cosmetics Pty Ltd.AustraliaFDAWarning Letter18-May-18 December 11 to 13, 2017FDF
Jilin Shulan Synthetic Pharmaceutical Co., Ltd.ChinaFDAWarning Letter14-May-18November 7 to 10, 2017API
Keshava Organics Pvt. Ltd.IndiaFDAWarning Letter15-Mar-18May 25 to 31, 2017API
Kolmar Korea Co., Ltd.South KoreaFDAWarning Letter18-May-18September 25 to 28, 2017FDF
Labocont Industrial SRLDominican RepublicFDAWarning Letter09-Mar-18June 5 to 9, 2017FDF
Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd.ChinaFDAWarning Letter19-Apr-18 October 16 to 20, 2017API
Luen Wah (HK) Medicine Ltd.Hong KongFDAWarning Letter06-Apr-18September 25 to 28, 2017FDF
Malladi Drugs & Pharmaceuticals Ltd.IndiaFDAWarning Letter09-Mar-18September 4 to 8, 2017API
McCallum Manufacturing Ltd.United KingdomFDAWarning Letter09-Apr-18July 24 to 26, 2017FDF
Nan San (HK) Pharmaceutical Factory Ltd.Hong KongFDAWarning Letter23-Feb-18September 25 to 29, 2017FDF
Nowcos Co., Ltd.South KoreaFDAWarning Letter14-Feb-18July 31 to August 4, 2017FDF
Nox Bellcow Cosmetics Co., Ltd.ChinaFDAWarning Letter09-May-18September 18 to 22, 2017FDF
Phase 4 Pharmaceutical LLCUnited StatesFDAWarning Letter18-Apr-18April 26 to May 2, 2017FDF
Polaroisin International Co., Ltd.TaiwanFDAWarning Letter25-Jan-18September 11 to 15, 2017FDF
Quali Controle & Qual-Controle-C.E.BacFranceFDAWarning Letter05-Mar-18September 14 to 15, 2017FDF
Reine LifescienceIndiaFDAWarning Letter09-May-18 October 30 to November 3, 2017API
Shanghai Weierya Daily Chemicals FactoryChinaFDAWarning Letter07-Feb-18April 10 to 14, 2017FDF
Sichuan Friendly Pharmaceutical Co., Ltd.ChinaFDAWarning Letter22-Jun-18October 23 to 27, 2017API
Taiwan Biotech Co., Ltd.TaiwanFDAWarning Letter31-May-18September 1 to 11, 2017FDF
Tris Pharma Inc.United StatesFDAWarning Letter26-Mar-18February 14 to March 20, 2017FDF
Wong Lap Kwong Medicine Company Ltd.Hong KongFDAWarning Letter11-Jan-18September 18 to 22, 2017FDF
Yicheng Chemical Corp.ChinaFDAWarning Letter02-Jan-18July 17 to 21, 2017API
Zhejiang Ludao Technology Co., Ltd.ChinaFDAWarning Letter23-Feb-18August 14 to 18, 2017FDF
Zhuhai United Laboratories Co., Ltd.ChinaFDAWarning Letter27-Jun-18September 11 - 15, 2017.API
Claris Injectables Ltd.IndiaFDAWarning Letter05-Jul-18July 27, 2017 to August 4, 2017FDF