FDA 483 - Vintage Chemical, Inc. - November 20, 2023

Vintage Chemical, Inc. in Fort Wayne, IN, was cited with three observations during an FDA inspection of its drug product manufacturing operations. The firm failed to establish adequate cleaning validation for non-dedicated equipment, conduct specific identity testing for incoming raw materials, and perform appropriate finished product potency testing prior to release. These deficiencies indicate significant gaps in the firm's quality control and adherence to Good Manufacturing Practices.