FDA 483 - Richard Wolf Medical Instruments Corp. - July 17, 2018

During an inspection conducted from June 26 to July 17, 2018, the FDA issued a Form FDA-483 to Richard Wolf Medical Instruments Corp., a medical device manufacturer. The inspection revealed multiple deficiencies in the company's quality system, which must comply with 21 CFR 820. Key violations included the inadequate establishment and implementation of corrective and preventive action (CAPA) procedures. Specifically, the firm failed to review complaint trends, conduct adequate effectiveness checks for closed CAPAs, and maintain complete supplier documentation for corrective actions. The CAPA procedure also lacked clear definitions for preventing product nonconformities.

Further issues involved insufficient procedures for ensuring purchased products and services conformed to requirements, particularly regarding third-party supplier corrective action requests. Organizational structure deficiencies were noted, with quality charts not updated, personnel requisitions lacking formal approval, and job descriptions not created. Complaint handling was inadequate, as investigation reports lacked performer and verifier signatures and dates. Additionally, equipment maintenance activities were undocumented, and changes to human resources documents did not follow the established engineering change order process. Richard Wolf Medical Instruments Corp. must address these observations by implementing comprehensive quality system procedures, improving documentation practices, and ensuring a compliant organizational structure.