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.
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.
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Enforcement included only two warning letters this week: we cover one BIMO warning letter and one issued to an OTC drug firm. The OTC firms continue to show that they have a limited grasp of the fundamentals of GMPs required for their product type. Also, Lupin announced that they received a warning letter but FDA has not yet published it.
GMP expert Jerry Chapman covers how Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence.
Lots of reading, including more to OTC manufacturers who continue to fail to understand and implement the fundamentals of GMPs. There is also one warning letter to a cell therapy manufacturer and one to a sponsor-investigator.