FDA 483 - Turnco Tool & Instrument, Inc. - February 11, 2026

Turnco Tool & Instrument, Inc., a contract manufacturer in Georgetown, TX, was cited for significant deficiencies in its quality system. The inspection revealed a lack of documented risk management processes for critical manufacturing steps like deburring and for undersized devices, despite receiving customer complaints. Additionally, the firm lacked documented procedures and acceptance criteria for controlling the deburring process for Class II devices, raising concerns about product conformity and patient safety.