# FDA 483 - Biomedical Research Models, Inc. d/b/a Biorep - May 29, 2026

Source: https://www.keypedia.com/records/483/biomedical-research-models-inc-dba-biorep/a9affee6-a345-4962-8143-b90be158b9c2

> FDA 483 for Biomedical Research Models, Inc. d/b/a Biorep on May 29, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomedical Research Models, Inc. d/b/a Biorep
- Inspection Date: 2026-05-29
- Product Type: other
- Office Name: New England District Office
- Summary: Biomedical Research Models, Inc. d/b/a Biorep, a nonclinical laboratory in Worcester, MA, was cited for significant data integrity issues during an FDA inspection. The study director failed to ensure accurate recording and verification of experimental data, leading to discrepancies between pathology reports and raw data concerning tissue collection and findings in non-clinical studies. This indicates a serious breakdown in data management and quality control for research models.

## Related Officers

- [Agata E. Libera](https://www.keypedia.com/people/agata-e-libera/ab9679b1-cd55-452e-bdf3-dd22f67f4e0c)
- [issuing_officer](https://www.keypedia.com/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.keypedia.com/companies/biomedical-research-models-inc-dba-biorep/0dcdb3ea-14c3-4b47-90dc-74f2fad65ab5

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144
