This week, one warning letter was issued to an HCT/P firm and three were issued to OTC manufacturers located outside the US.
FDA posted four GMP drug warning letters, all to firms outside the US. One of the letters reinforces the need to monitor import alerts to ensure that suppliers and CMOs are not on the list; the consequences of missing this can be serious as this firm learned.
This week we cover three warning letters: two to pharma firms and one to a clinical investigator.
Among FDA-posted warning letters this week, the Center for Tobacco Products posted four warning letters, one GMP drug warning letter from CDER and yet another, the 4th, warning letter regarding failure to comply with the Foreign [Food] Supplier Verification Program (FSVP) posted this week.
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.
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.
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.
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.