Robert McElwain FDA

Mr. McElwain Received his B.S. in Biology at Gannon University in Erie, PA in 1998 and his M.S. in Environmental Microbiology at West Virginia University in 2002. He has been with FDA for approximately 10 years. He has worked in CBER’s Office of Compliance and Biologics Quality / Division of Case Management for the past 6. He is responsible for reviewing 483’s, Establishment Inspection Reports (EIR’s) and firm’s responses in an effort to make final inspection classification decisions. He is also responsible for all inspection follow-up activities including drafting Untitled and Warning Letters, organizing regulatory meetings, and following up on firm’s post-inspection commitments.