# FDA 483 - Bioreliance Corporation - November 22, 2024

Source: https://www.globalkeysolutions.net/records/483/bioreliance-corporation/0a91692f-a886-49cb-a834-736dbccf3145

> FDA 483 for Bioreliance Corporation on November 22, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioreliance Corporation
- Inspection Date: 2024-11-22
- Product Type: other
- Office Name: Baltimore District Office
- Summary: Bioreliance Corporation in Rockville, MD, a control testing laboratory, was cited for two observations during an FDA inspection. The firm failed to thoroughly review unexplained discrepancies and out-of-specification results, lacking scientific justification for retesting and assigning root causes. Additionally, the firm's practice of retesting OOS samples based on client memoranda lacked documentation for qualified dilutions and justification for changes in dilution factors.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/bioreliance-corporation/b0edcd89-77c9-4465-990a-45d7a062c755)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)

Company: https://www.globalkeysolutions.net/companies/bioreliance-corporation/08d3dc20-6c7e-4f04-bb98-bbc868e70000

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa