List of Companies – cGMP Non-Compliance Recap – Mid 2018

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Date of Inspection
Date of Inspection
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

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