FDA 483 - Kerber USA Inc. - November 02, 2022

Kerber USA Inc., a medical device manufacturer in Amherst, NY, was cited with seven observations during an FDA inspection. The firm lacks fundamental quality system procedures across multiple critical areas, including design control, complaint handling, corrective and preventive actions, quality audits, device history records, supplier control, and nonconforming product control. This indicates a severe absence of a compliant quality management system for their medical device manufacturing operations.