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...]
Frontida BioPharm, Inc Receives Significant Warning Letter for Cross Contamination (08/15/16)
 Frontida BioPharm, Inc. receives a significant warning letter for cross contamination (08/15/16) during an audit that extended from June 15 through July 17, 2015. The FDA deemed the drug products adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 351(a)(2)(B). The FDA investigators … [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...]
