FDA 483 - V-Ensure Pharma Technologies Pvt. Limited - May 17, 2024

V-Ensure Pharma Technologies Pvt. Limited, a drug contract manufacturer, was cited for deficiencies in its stability program. The firm failed to assure that long-term stability samples for a drug product were tested in the same container-closure system as marketed. This deviation from protocol and a prior agency commitment could impact the accuracy of analytical results.