FDA 483 - Biorez, Inc - August 04, 2023

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.