FDA 483 - Comparative Biosciences, Inc - July 30, 2024

An FDA inspection of Comparative Biosciences, Inc. in Sunnyvale, CA, revealed significant Good Laboratory Practice (GLP) deficiencies. Observations included failures to properly document protocol changes, provide adequate separate laboratory space for BSL-2 studies, and ensure equipment was adequately inspected, cleaned, and maintained with appropriate records. These issues compromise study integrity and biosafety.