FDA 483 - Omega Biological Laboratories Inc. - July 31, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 5fa7d69a-285d-41d4-949b-8b1dc90fb9e3