# FDA 483 - Bioreliance Corporation - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/bioreliance-corporation/b0edcd89-77c9-4465-990a-45d7a062c755

> FDA 483 for Bioreliance Corporation on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioreliance Corporation
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: The FDA inspected BioReliance Corporation, a non-clinical laboratory in Rockville, MD, from August 6-8, 2019. The inspection revealed several deficiencies related to personnel training, responsibility assignment, material retention, and quality assurance unit oversight. These observations indicate a need for improved controls in the firm's operations.

## Related Documents

- [483 - 2024-11-22](https://www.globalkeysolutions.net/records/483/bioreliance-corporation/0a91692f-a886-49cb-a834-736dbccf3145)

## Related Officers

- [Byungja E. Marciante](https://www.globalkeysolutions.net/people/byungja-e-marciante/5d1f2927-9017-4ab6-8ad2-521e340ef14f)
- [issuing_officer](https://www.globalkeysolutions.net/people/charles-r-bonapace/f1056c3d-2384-48e0-812d-202ca96ae710)
- [issuing_officer](https://www.globalkeysolutions.net/people/mark-j-seaton/640c2deb-25ff-4e2e-8f48-d15d31f9c5bf)
- [issuing_officer](https://www.globalkeysolutions.net/people/zhou-chen/03362438-eba1-4010-b6b1-5cccf25a824c)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e