Lots of warning letters this week issued by the Center for Tobacco Products, including 22 to firms selling flavored, cartridge-based electronic cigarettes. FDA also posted one issued to a drug manufacturer and one to a clinical investigator. We cover the latter two here. And, the Cipla warning letter we referenced last week has not been posted yet.
Enforcement this week included a collection of warning letters including three device warning letters and three drug GMP warning letters, including one to a fertility clinic governed under 21 CFR 1271. And, warning letters to firms touting treatments for the coronavirus disease finally started appearing.
After three weeks of no warning letters, this week the FDA posted five drug GMP warning letters and three device GMP warning letters.
We cover one device warning letter and review a mislabeling of PURELL Hand Sanitizer.