FDA 483 - Strauman Manufacturing Inc.

An FDA inspection of Straumann Manufacturing in Arlington, TX, from January 11-14, 2021, revealed a repeat observation regarding the firm's failure to establish adequate procedures for corrective and preventive actions (CAPA). Specifically, the firm did not consistently conduct root cause investigations or initiate CAPAs for identified nonconformities documented in their Exception Reports. This indicates a significant deficiency in their quality management system.