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.
FDA posted three drug warning letters this week, one of which was issued regarding combination products. FDA’s requests for “independent” assessments continue.
An FDA drug investigator reports on the ways SOPs and data can introduce unneeded risks in quality management systems.
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.
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.