FDA 483 - Peace Medical Inc. - January 14, 2025

An FDA inspection of Peace Medical Inc., a medical device manufacturer in Wharton, NJ, revealed significant deficiencies in their quality system. Observations included inadequate purchasing controls, a failure to implement Unique Device Identifiers (UDI) on device labels, and a lack of submission of required device information to the Global Unique Device Identification Database (GUDID). These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing and labeling.