FDA 483 - Philosys Co. Ltd - March 30, 2023

Philosys Co. Ltd, a medical device manufacturer in Gunsan, Korea, was inspected by the FDA from March 27-30, 2023. The inspection revealed significant deficiencies in quality system record maintenance, specifically the failure to retain original equipment printouts, and inadequate employee training on updated procedures for Medical Device Reporting and Customer Complaints. These issues indicate a lack of adherence to established quality system requirements.