FDA 483 - Daniels Manufacturing Operations Inc - November 08, 2023

Daniels Manufacturing Operations Inc, a contract manufacturer in Racine, WI, was cited for multiple deficiencies in its quality management system. The inspection revealed inadequate documentation of corrective and preventive actions, insufficient procedures for equipment calibration and maintenance, and a complete lack of quality audit procedures. Furthermore, management failed to conduct required reviews of the quality system and ensure the quality policy was understood by employees.