Join Govzilla’s GMP Quality Expert Jerry Chapman for an informative 1-hour webinar on assessing legacy products for potential GMP compliance gaps and pitfalls.
A busy week for enforcement. Included in this week of warning letters are Dollar Tree (in which FD&C Act is cited rather than CFR), Cadila Healthcare Limited, and Mylan Laboratories Limited among others.
Yet another week with a preponderance of warning letters issued by the Center for Tobacco Products. We cover one warning letter issued to an OTC manufacturer in China.
A slow week for drug and device warning letters as FDA continues their enforcement focus on e-cigarette suppliers. Enforcement this week includes a lone GMP warning letter to a PET drug manufacturer.
Health authorities worldwide have overseen the recall of many ‘sartan’ products in the past few years. These recalls began in the US as early as 2013 with a recall of product by Teva Pharmaceuticals. Here, we address some of the enforcement actions taken against a few of the notable players in this series of events.
Enforcement this week includes only two drug warning letters, one of which was issued to a PET drug manufacturer. Firms that are bedeviled by mold findings in both surface and personnel EM would be well served to read this warning letter and the one issued to a sister site last year.
Looking at the most recent publication of GMP drug inspection data from CDER, we examine data from FY2018 and evaluate six years’ worth of trends in GMP inspection enforcement.