FDA 483 - Bertec Corp - February 12, 2024

An FDA inspection of Bertec Corp in Columbus, OH, from February 6-12, 2024, revealed a significant issue with the firm's purchasing controls. The company failed to establish adequate procedures to ensure purchased products and services conform to specified requirements. Specifically, Bertec Corp did not complete evaluations of critical suppliers or maintain evidence of quality agreements as required by their own documented procedures.