483
Omega Biological Laboratories Inc.Omega Biological Laboratories Inc. – FDA 483, Jul 31, 2025
Record Details
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.
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ID · 5fa7d69a-285d-41d4-949b-8b1dc90fb9e3
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