CHMP RECOMMENDS RECALL OF SELECTED BATCHES MFG AT BEN VENUE SUMMARY A joint GMP inspection of the Ben Venue site, where a number of sterile medicines are manufactured, by the UK and French medicines regulatory agencies together with the US FDA on 7-11 November 2011 highlighted several shortcomings in the quality management system, particularly in relation to the aseptic … [Read more...]
CHINESE API MANUFACTURING FACILITIES RECEIVE WARNING LETTER (MARCH 30, 2011)
NINGBO SMART PHARMACEUTICAL RELEASE WITH INCOMPLETE C of As Comment The Ningbo Smart Pharmaceutical Co. Ltd, Ningbo China, received an Active Pharmaceutical Ingredient (API) audit between October 25-29, 2010. During this audit, the investigator identified significant deviations from CGMP for the manufacture of APIs. They … [Read more...]
FDA ORDERS SEIZURE OF TRIAD PRODUCT WORTH $6 MILLION
FDA Orders Seizure Of Antiseptic, Antifungal Products Worth $6 Million The AP (4/6) reported that the Food and Drug Administration "said Wednesday that antiseptic products made by Triad Group and H&P Industries were seized to prevent the distribution of products that might be contaminated and pose a health risk." At the FDA's request, US Marshals seized more than "$6 … [Read more...]
Johnson & Johnson McNeil-PPC Consent Decree and Permanent Injunction
Johnson & Johnson McNeil-PPC Consent Decree and Permanent Injunction Comment The recent Consent Decree and Permanent Injunction against McNeil-PPC and two of its Vice Presidents recalled an article from March 2010 re: "FDA Recommends Increased Criminal Prosecutions of Responsible Corporate Officials...". The initial paragraph is enclosed below. … [Read more...]
Barry A Friedman, PhD LLC
Barry A Friedman, PhD LLC PURPOSE AND SCOPE The purpose of this Web Site is to share with the FDA regulated community recent activities within the FDA and the USP that you may find of interest. This will include, in particular, Warning Letters and their application to your various activities. It will also focus upon new drafts of Guidance for Industry … [Read more...]
