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.
FDA posted three drug warning letters this week, one of which was issued regarding combination products. FDA’s requests for “independent” assessments continue.
FDA published five GMP drug warning letters and one to a device maker. FDA frequently requests “independent” assessments indicating that they do not think the firms are capable of performing these activities internally.
Enforcement this week included two drug GMP warning letters, both to firms in the US.
We review FY2018 FDA Human Tissue and Cell Therapy Observations and trends since FY2015.
Enforcement includes one untitled letter and one warning letter to cell therapy companies. Also, FDA posted and then removed one warning letter to a device manufacturer.