As the global leader in and wind vane for drug regulation, the U.S. FDA’s management measures for the pharmaceutical industry and regulation trend have been the focus of pharmaceutical practitioners. FDA issued 17 warning letters on production quality (including 6 in January, 7 in February, and 4 in March) in 2018 Q1, with the specific information as shown in the following table:
Table 1 Basic Information of FDA’s Warning Letters in 2018 Q1
|
Company name |
Product problem |
Issuing time |
|
Keshava Organics Pvt. Ltd. (India) |
API not complying with cGMP, adulterated |
March 15, 2018 |
|
Labocont Industrial SRL (Dominica) |
Preparation not complying with cGMP, adulterated |
March 9, 2018 |
|
Malladi Drugs & Pharmaceuticals Limited (India) |
API not complying with cGMP, adulterated |
March 9, 2018 |
|
Quali-Controle & Quali-Controle C.E.BAC (France) |
Preparation not complying with cGMP, adulterated |
March 5, 2018 |
|
Nan San (HK) Pharmaceutical Factory |
Preparation not complying with cGMP, adulterated |
February 23, 2018 |
|
Zhejiang Ludao Technology Co., Ltd. |
Preparation not complying with cGMP, adulterated |
February 23, 2018 |
|
Alchymars ICM SM Private Limited (India) |
API not complying with cGMP, adulterated |
February 16, 2018 |
|
Nowcos Co., Ltd. (South Korea) |
Preparation not complying with cGMP, adulterated |
February 14, 2018 |
|
Casmara Cosmetics, S.A. (Spain) |
Preparation not complying with cGMP, adulterated |
February 12, 2018 |
|
Shanghai Weierya Daily Chemicals Factory |
Preparation not complying with cGMP, adulterated |
February 7, 2018 |
|
Cosmecca Korea Co., Ltd. (South Korea) |
Preparation not complying with cGMP, adulterated |
February 2, 2018 |
|
Celltrion, Inc. (South Korea) |
Preparation not complying with cGMP, adulterated |
January 26, 2018 |
|
Polaroisin International |
Preparation not complying with cGMP, adulterated |
January 25, 2018 |
...









(All Rights Reserved)