FDA 483 - DimcoGray Inc. - February 09, 2023

DimcoGray Inc., a contract manufacturer in Centerville, OH, was inspected by the FDA from February 6-9, 2023. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures, specifically concerning the timely completion of risk analyses and priority ratings for CAPAs. This indicates a moderate level of non-compliance with quality system requirements.