# FDA 483 - Biorez, Inc - August 04, 2023

Source: https://www.globalkeysolutions.net/records/483/biorez-inc/b6ff8489-2d73-43a1-a712-68d2a3680869

> FDA 483 for Biorez, Inc on August 04, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biorez, Inc
- Inspection Date: 2023-08-04
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Biorez, Inc. in New Haven, CT, a medical device establishment, revealed a significant issue regarding the lack of adequately established procedures for ensuring purchased services conform to specified requirements. Specifically, the firm used an unvalidated protocol for the sterilization of its Biobrace implant, indicating a serious lapse in quality control for a critical process.

## Related Officers

- [Power Trader/Data Scientist](https://www.globalkeysolutions.net/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.globalkeysolutions.net/companies/biorez-inc/b3836b32-8e27-4cd7-a515-84ba4b0e3ac0

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7