FDA’s Top Ten Drug GMP Inspection Citations

At the 2017 FDA/Xavier University PharmaLink conference Robert Tollefsen, an FDA National Expert Investigator – Drugs/Computers, Pharmaceutical Inspectorate/Level III Certified in Drugs, Medical Products and Tobacco Program Operations Branch, and Dell Moller, FDA Cincinnati District Supervisory Investigator, presented FDA’s top ten drug GMP inspection citations for FY 2016. This article includes a brief comment/analysis on the findings and additional information regarding inspection trends and other inspection findings.