FDA 483 - Pathen Medical LLC - November 01, 2019

An FDA inspection of Pathen Medical LLC, a medical device manufacturer, was conducted from October 31 to November 1, 2019, in Sanford, FL. The inspection identified critical quality system deficiencies, resulting in the issuance of an FDA Form 483.

The main observations focused on the company's inadequate controls over suppliers and contractors. Specifically, Pathen Medical LLC failed to properly evaluate and select third-party sterilization companies, particularly when sterilization services were sub-contracted. This oversight led to an incomplete assessment of the sterilization process utilized for their 'Administration Sets.'

Additionally, the inspection revealed significant issues with the validation of the sterilization process. The Physical Performance Qualification (PPQ) was deemed inappropriately designed because key process parameters used during validation did not align with those implemented for routine manufacturing. For example, crucial sterilization parameters such as temperature, pressure, and exposure times varied between the validation protocol and standard production procedures, raising concerns about product sterility assurance.

These findings underscore the necessity for Pathen Medical LLC to strengthen its compliance with medical device quality system regulations, particularly concerning purchasing controls and process validation. The company is required to investigate these observations, implement robust corrective actions, and provide a formal response to the FDA detailing its plans to address the identified issues and ensure continuous adherence to quality and safety standards.