FDA 483 - Pathy Medical, LLC - November 19, 2024

During an inspection conducted by the FDA from October 23 to November 19, 2024, medical device manufacturer Pathy Medical, LLC received a Form FDA-483 citing significant observations regarding its quality system. The company failed to conduct regular management reviews of its quality system as required by its own procedures, with no documented reviews in 2021, 2022, or for recent data from 2023 and 2024. Furthermore, Pathy Medical’s corrective and preventive action (CAPA) procedures were found to be inadequate. Multiple CAPAs initiated nearly a year prior, addressing issues like out-of-tolerance conditions and internal audit findings, had not been implemented or effectively mitigated. Finally, the inspection revealed a lack of adequate monitoring and control for validated process parameters, specifically the absence of required bioburden level testing for the Light Jacket device's sterilization process since March 2021. Pathy Medical is required to address these observations by implementing comprehensive corrective actions to ensure compliance with medical device quality system regulations.