FDA 483 - Omega Biological Laboratories Inc. - July 31, 2025

An FDA inspection of Omega Biological Laboratories Inc., a contract testing laboratory in Lyndhurst, NJ, revealed significant deficiencies in their quality control systems. The firm failed to thoroughly investigate out-of-specification sterility test results and lacked adequate environmental and personnel monitoring procedures. Additionally, the inspection found issues with laboratory record retention, equipment qualification, and verification of microbial strains and biological indicators.