FDA 483 - Vesta Pharmaceuticals, Inc. - February 09, 2024

An FDA inspection of Vesta Pharmaceuticals, Inc. in Indianapolis, IN, a dietary supplement manufacturer, revealed significant deficiencies in quality control and material management. Observations included incomplete batch production records, unverified instrument calibration logs, and improper storage of quarantined and expired materials. These issues indicate a lack of adequate controls over manufacturing processes and product integrity.