Yusef Manufacturing, Clearfield, UT was audited by the FDA from May 23 – 26, 2016. Subsequent to the audit the firm received a total of five citations relating to 21 CFR 211.22(d) (1)(2); 84(d) (1), (2); 100 (a); 192; 165(a), (b). Because of an on-going history of a failure to correct similar citations, the FDA issued the enclosed Warning Letter. In … [Read more...]
U.S. Food and Drug Administration (FDA) Inspection Cites Chinese Firm for API Issues – Includes Import Alert and Warning Letter
The U.S. Food and Drug Administration (FDA) inspected manufacturing facilities,  Changzhou Jintan Qianyao Pharmaceutical Raw Materials, from February 13-17, 2017. As a result of significant deviations from current good manufacturing practice (CGMP), the FDA placed the firm on Import Alert 66-40 on May 4, 2017. Subsequent to … [Read more...]
Porton Biopharma, Limited, Salisbury Received a Warning Letter (01/17/17)
Porton Biopharma, Limited, Salisbury received a Warning Letter following their most recent audit (View Link). Porton Biopharma, Limited, Salisbury, was audited from March 7-18, 2016 as a follow-up to an audit conducted January 12-23, 2015 wherein similar findings were observed. The repetition of these findings were observed to be so substantial that the FDA will … [Read more...]
Teva Pharmaceutical Works Pvt. Ltd. Receives “Microbiologically Loaded” Warning Letter
Teva Pharmaceutical Works Pvt. Ltd. receives "Microbiologically Loaded" Warning Letter (Click Here)Â as a result of a FDA inspection which occurred from January 21 -29, 2016. As a result of this inspection, a Form FDA 483 and a Warning Letter (October 13, 2016) were issued. The Warning Letter consisted of seven citations, many of them dealing with media fills and … [Read more...]
NIPPON FINE CHEMICAL CO RECEIVES IMPORT ALERT AND WARNING LETTER FOR REFUSAL TO ADMIT
Nippon Fine Chemical recently received a Form FDA 483 (December 14, 2015), followed by an Import Alert (August 8, 2016) and a Warning Letter (Click Here) (September 26, 2016) for adulterated products that were produced at their drug manufacturing facility, Nippon Fine Chemical Co., Ltd, located at 1-1, 5-Chome, Umei, Takasago City, Hyogo. The FDA investigator documented that … [Read more...]
