FDA 483 - Cathtek LLC - February 27, 2025

An FDA inspection of Cathtek LLC, a contract manufacturer in Walkertown, NC, revealed significant deficiencies in their quality system. The firm failed to adequately document corrective and preventive action activities, specifically an open CAPA for over 24 months without resolution. Additionally, the inspection found a lack of documentation for equipment maintenance activities, including preventive and corrective maintenance records for assembly machines and other components.