FDA 483 - Pac-dent International, Inc. - March 12, 2026

An FDA inspection of Pac-dent, Inc. in Brea, CA, a specification developer/repackager/relabeler of Class II devices, identified two significant observations. The firm failed to submit required Unique Device Identifier (UDI) information for commercially distributed devices to the GUDID database and lacked written UDI procedures. Additionally, the firm did not maintain records of re-evaluation for a critical supplier and its procedures did not address critical supplier re-evaluation.