FDA Warning Letters Week of 11/3/2019: Lost Documentation and Data Integrity

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.

How Key Pharma and Device Executives Are Developing the Next Generation of Quality Professionals and Leaders

A team comprising over a dozen chief quality officers (CQOs) representing the medical device, pharmaceutical, animal health, and consumer healthcare industries has pooled its collective passion and wisdom – with input from FDA and other drug and device regulatory agencies – to establish and implement an innovative education curriculum that will help develop the next generation of scientists entering the industry.

FDA Warning Letters Week of 10/27/2019: Sterility and Spores

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.

Enforcement Actions Against Sartan Manufacturers

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.

Week of October 20th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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.


Week of October 13th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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.

OCP Guidance

Office of Combination Products Official Details Rulemaking and Guidance Agenda

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.


Week of October 6th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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.