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...]
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...]
FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2015 – NOW AVAILABLE
TOP FOUR OBSERVATIONS RETAIN SIMILAR ORDER TO 2013 AND 2014 Each fiscal year the FDA issues the various FDA 483 Observations from the various Centers to include CBER, CDER, CDRH, etc. This Blog focuses only upon those issued by the Center for Drug Evaluation and Research (CDER) and will concentrate upon those FDA' CDER listing found within 21 CFR Part … [Read more...]
Ps. Aeruginosa Exceeds 2.1 X 107/Gm in Product; Where was the Microbiologist?
Questions often arise regarding when is a microorganism “specified” vs. “objectionable”? USP<62> lists a total of seven individual and groups of microorganisms to include Ps. aeruginosa that are considered “specified”. However, in a broader category they are also considered as “objectionable”. A recent Warning Letter discusses the microbiological results from a … [Read more...]
