FDA EIR - Avita Medial Americas Llc - February 23, 2018

Parker Hannifin Corporation's medical device manufacturing facility in Ventura, CA, was inspected by the FDA from February 20-23, 2018. This routine inspection, conducted under C.P. 7382.845 for medical device manufacturers and employing a Level I QSIT approach, focused on the Corrective and Preventive Action (CAPA) and Production & Process Controls subsystems. The facility, a contract manufacturer of various sterile and non-sterile medical devices, is slated for closure by June 2018, with manufacturing operations relocating to its sister facility in Merrillville, IN. Although no FDA Form 483 was issued due to the impending relocation, the inspection identified several significant issues requiring corrective action. These included incomplete complaint records, lacking full investigations and determinations for Medical Device Reporting. Non-conforming Material Reports were found to be incomplete, specifically missing justifications for 'as is' product use and evaluations of rework. Device History Records did not consistently document verification of sterilization records. Additionally, the company failed to take action in response to out-of-specification cleanroom pressure differential readings, and its procedures lacked clear instructions for such events. Lastly, calibration records were incomplete, as they did not document initial out-of-tolerance measurements, which is crucial for investigating potential product impact. Management acknowledged these deficiencies and committed to addressing all identified issues.