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

Source: https://www.globalkeysolutions.net/records/483/omega-biological-laboratories-inc/5fa7d69a-285d-41d4-949b-8b1dc90fb9e3

> FDA 483 for Omega Biological Laboratories Inc. on July 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Omega Biological Laboratories Inc.
- Inspection Date: 2025-07-31
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/michael-o-idowu/795647ab-8f6b-47cc-ae88-3b2c61192861)
- [Investigator](https://www.globalkeysolutions.net/people/janet-a-rajan/95741927-9a4d-422b-bd51-01783d962cbe)

Company: https://www.globalkeysolutions.net/companies/omega-biological-laboratories-inc/20fd4f57-0cca-4da6-8bc5-7ea616d0a0d1

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248