FDA 483 - Kerber USA Inc. - November 07, 2025

An FDA inspection of Kerber USA Inc., a medical device manufacturer in Amherst, NY, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures and document records for device history, design validation and verification, complaint handling, corrective and preventive actions, design changes, equipment calibration, and management reviews. Additionally, UDI information was not properly provided to the Global Unique Device Identification Database or included on device labels.