FDA’s Record-Number GMP Warnings In FY 2019 Included First Of A Kind

The US Food and Drug Administration not only submitted a record number of drug good manufacturing practices warning letters in fiscal year 2019, its Office of Manufacturing Quality also sent its first warning to a distributor about adulterated drugs.

The warning to the Dollar Tree US retail chain about receiving adulterated OTC drugs isn’t a signal that the agency is focusing its drug GMP inspection resources on distributors, says Donald Ashley, director of the Center for Drug Evaluation and Research’s Office of Compliance