FDA 483 - Pharmasept Medical Products 1995 Ltd. - June 22, 2023

Pharmasept Medical Products 1995 Ltd. underwent an FDA inspection from June 19-22, 2023, which identified several significant deviations from quality system regulations. The medical device manufacturer was cited for inadequacies in its Corrective and Preventive Action (CAPA) procedures, including inconsistent investigations into root causes of quality issues, lack of verification for proposed actions, and poor information dissemination. The inspection also revealed that the sterilization process for devices like ultrasound transducer covers and gel was not fully validated, with incomplete protocols for load density and sterilization components.

Further observations included insufficient procedures for qualifying laboratory service suppliers, particularly regarding investigations of unexpected results. The company's Medical Device Report (MDR) procedures were not adequately defined, lacking clarity on reportable events, key terms, and documentation. Documentation for receiving acceptance activities of sterilized products was also found to be deficient. Finally, the document approval process was deemed inadequate, with electronic signatures not meeting regulatory requirements, raising concerns about the integrity and authenticity of electronic records. Pharmasept is required to implement thorough corrective actions to address these observations and ensure compliance with medical device quality system regulations.