Freudenberg Medical, Llc – FDA 483, May 15, 2026

Freudenberg Medical, LLC in Jeffersonville, IN, was cited for four observations during an FDA inspection concerning its quality system. The firm demonstrated deficiencies in supplier verification activities, lacked documented statistical techniques for data analysis and identifying negative quality trends, and failed to adequately implement corrective actions for recurring nonconformities. Additionally, complaint investigations were found to be incomplete, not fully reviewing all relevant batch records.