FDA 483 - Vintage Chemical, Inc. - November 19, 2025

An FDA inspection of Vintage Chemical, Inc. in Fort Wayne, IN, from November 12-19, 2025, revealed eight significant observations. The firm demonstrated a severe lack of adherence to Current Good Manufacturing Practices, including failures in quality control, process validation, equipment management, and facility maintenance. These deficiencies indicate a systemic breakdown in ensuring the identity, strength, quality, and purity of drug products manufactured at the facility.