We cover one device warning letter and review a mislabeling of PURELL Hand Sanitizer.
We examine data from FY2019 and a total of five years’ worth of trends in GMP inspection enforcement in this area.
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.
FDA posted three drug warning letters this week, one of which was issued regarding combination products. FDA’s requests for “independent” assessments continue.