Prepare For An FDA Bioburden Inspection

By Anastasia G. Lolas / M.Sc., Visionary Pharma Consulting LLC

Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips.

Even with effective prevention, bioburden incidents can occur. A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help improve processes and procedures.