FDA 483 - Vintage Chemical, Inc. - November 19, 2025
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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.
ID · 80b6ce9f-4fbc-48b3-b0a2-da9fb6e86956