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.
Another busy week on the warning letter enforcement front. We address one warning letter to a device firm, one to a fertility clinic with similar issues to one posted last week, and four to drug firms. This includes the warning letters to Glenmark and Torrent located in India, both of which were announced last week but not yet posted by FDA.
GMP expert Jerry Chapman covers the presentation by FDA Office of Combination Products (OCP) Associate Director for Policy John Barlow Weiner in which he reviews PMSR guidance and implementation, the RFD process, and new guidance in progress.
In the areas we cover, there was only one posted warning letter to a fertility clinic, but we also cover two announced warning letters that FDA has not yet published.
When observations are identified during an inspection, it is FDA’s expectation that a firm will remediate the issues. This expectation is even more important if a firm receives a warning letter. Lupin Limited (India) seems to have come up short on both accounts.
In another first-of-a-kind set of warning letters, the FDA and DEA issued joint warning letters to four online networks which are marketing unapproved opioid medicines. Also, we include the warning letter issued to Lupin Limited which seems to show they haven’t corrected their shortcomings since the November 2017 warning letter.