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...]
HEBEI YUXING BIO-ENGINEERING CO LTD RECEIVES FDA WARNING LETTER (09/06/2016)
Hebei Yuxing Bio-Engineering Co Ltd received a FDA Warning Letter (Click Here) on September 6, 2016. This Warning Letter came as a result of an audit from August 17-21, 2015 and the issuing of a subsequent Import Alert in July 2016. As has often been the situation, Hebei Yuxing Bio-Engineering was placed on the FDA’s Import Alert list on July 8, 2016. Since no other … [Read more...]
