Maan Abduldayem FDA

Maan  Abduldayem

Maan Abduldayem FDA

Maan Abduldayem, is a Branch Chief in the Office of Manufacturing Quality/Division of Drug Quality-I.  Maan has a Bachelor in Biomedical Instrumentation, and Master Degree from Johns Hopkins University. Maan started as a Biomedical Engineer responsible for commissioning laboratory and hospital equipment. He worked in a vaccine manufacturing facility for 11 years, responsible for the manufacturing of drug substances for Acellular Pertussis and Meningitis Group C vaccines. In 2008, Maan joined the FDA as a case reviewer of biotech manufacturing applications, focused on the assessment of microbiological controls. Currently, Maan is a Branch Chief who oversees the evaluation of establishment inspection reports for Branch 2 of DDQ-I. He oversees the work of Compliance Officers and is responsible for the review of information collected during inspections and responses submitted by industry to 483 observations. As part of his responsibilities, he also reviews the initial Official Action Indication (OAI) recommendations from the field (Official Action Indicated) and the review of regulatory actions proposed against non-compliant firms. Maan also meets with industry on a regular basis to evaluate corrective actions implemented and commitments made by the regulated industry.