# FDA 483 - Bioreliance Corporation - January 29, 2026

Source: https://www.keypedia.com/records/483/bioreliance-corporation/672a1c90-d840-45b0-bc88-e5785ab1771d

> FDA 483 for Bioreliance Corporation on January 29, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioreliance Corporation
- Inspection Date: 2026-01-29
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: BioReliance Corporation in Rockville, MD, a nonclinical laboratory, received a Form 483 with two observations. The inspection revealed failures by the study director to ensure protocol adherence, including conducting required risk assessments for non-GLP procedures. Additionally, the study director failed to note and resolve unforeseen circumstances, such as animal strain discrepancies and positive bacterial detections, which could impact study quality and integrity.

## Related Documents

- [EIR - 2008-09-29](https://www.keypedia.com/records/eir/bioreliance-corporation/9e3d8b23-44f6-4814-bc27-750fefd4cc3b)
- [EIR - 2018-07-13](https://www.keypedia.com/records/eir/bioreliance-corporation/4b7d144e-2850-4fc9-8a87-54e30822e3c8)
- [EIR - 2019-08-08](https://www.keypedia.com/records/eir/bioreliance-corporation/806b06f3-c04a-4a12-81af-59e936cc50d5)
- [483 - Unknown Date](https://www.keypedia.com/records/483/bioreliance-corporation/b0edcd89-77c9-4465-990a-45d7a062c755)
- [483 - 2024-11-22](https://www.keypedia.com/records/483/bioreliance-corporation/0a91692f-a886-49cb-a834-736dbccf3145)

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.keypedia.com/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)

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

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64