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...]
Pharmaceutical Pharmakon Fails to Recall all Non-Expired Drug Products Intended to be Sterile – Then Changes its Mind
The FDA on April 11, 2016 notified pharmaceutical, Pharmakon Pharmaceuticals, Inc, Noblesville, IN that all sterile operations at their facility should cease until appropriate corrective actions have been implemented by the facility and recall all non-expired drug products that are intended to be sterile. A day later (April 12, 2016), Pharmakon informed FDA that it … [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...]
COMPANY RECEIVES WARNING LETTER FOR EXCEEDING MICROBIAL SPECIFICATIONS
Chemolee Lab Corporation Receives Warning Letter (022316) (Click Here) Investigators from the U.S. Food and Drug Administration (FDA) inspected Chemolee Lab Corporation, located at 3820 Conflans Road, Irving, Texas from January 12 thru February 13, 2015 and found a number of CGMP violations for exceeding microbial specifications. These included: Your firm failed to … [Read more...]
Compounding Pharmacies’ Observations Correlate With Those From Large Pharma ISO 5 Facilities
Compounding pharmacies continue to receive citations from the FDA (both Form FDA 483s and Warning Letters) for a continuing failure to meet 21 CFR 210/211 requirements. All one needs to do is visit FDA’s Electronic Reading Room to learn of the ORA audits and the subsequent citations. Even after the New England Compounding Center … [Read more...]
