483
V-Ensure Pharma Technologies Pvt. LimitedV-Ensure Pharma Technologies Pvt. Limited – FDA 483, May 17, 2024
Record Details
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.
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ID · d38bf8f3-655a-4884-bbbc-05a2a84640ce
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