FDA 483 - Gergens Orthodontic Lab - October 24, 2025

An FDA inspection of Gergens Orthodontic Lab in Dunlap, IL, revealed five significant observations, including two repeat findings, indicating serious deficiencies in their quality system. The firm failed to adequately establish complaint handling procedures, conduct required management reviews, and properly document design validation for their Class II medical devices. Additionally, the company did not comply with Unique Device Identification (UDI) requirements, including database registration and proper device labeling.