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...]
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...]
Bacterial Contamination (B. cepacia) Leads to Product Recall
PharmaTech LLC Issues Voluntary Nationwide Recall of Diocto Liquid Distributed by Rugby Laboratories Due to Product Contamination For Immediate Release July 15, 2016 Contact Consumers Rugby®'s Customer Support Department 1-800-645-2158 Media Brett Ludwig (215) 970-0153 Announcement View Product Photos PharmaTech LLC of Davie, FL, the … [Read more...]
ITALIAN PHARMACEUTICAL FIRM SLAMMED FOR MICROBIOLOGICAL ISSUES (05/20/16)
An Italian pharmaceutical firm, Corden Pharma Latina S.p.A, Italy, was inspected from May 21-29, 2015. As a result of this audit the FDA issued a Warning Letter on May 20, 2016. The Warning Letter summarized cGMP violations for finished pharmaceuticals, 21 CFR parts 210 and 211 as well as significant deviations from cGMP for active pharmaceutical ingredients (API). Because the … [Read more...]
