FDA 483 - SMITHWORKS, INC. - August 29, 2023

SMITHWORKS, INC., a medical device manufacturer in Lindale, TX, was cited with eight observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality system, including failures to maintain device master records, establish procedures for design changes, acceptance activities, nonconforming product control, complaint handling, quality audits, and corrective and preventive actions. Additionally, the firm lacked written Medical Device Reporting (MDR) procedures, indicating a broad lack of fundamental quality system controls.