Michael Klapal MSc U.S. FDA

Michael Klapal is a compliance officer in CDER's Office of Manufacturing Quality. In this role, he is responsible for conducting CGMP compliance assessments related to drug manufacturing facilities. His duties include evaluating inspection reports, sample dispositions, and assessing requests for regulatory discretion. Michael previously worked in CDER's Office of Pharmaceutical Quality, performing application and facility assessments, and as an investigator with the Office of Regulatory Affairs conducting inspections of pharmaceutical manufacturers.