FDA 483 - Nostrum Laboratories Inc - April 21, 2021

An FDA inspection of Nostrum Laboratories Inc, a drug manufacturer in Kansas City, MO, revealed significant deficiencies in their quality system. The firm failed to adequately investigate product complaints for low bottle counts and did not extend investigations to other potentially affected batches. Additionally, the inspection found a systemic failure to follow written procedures for internal and external audits, vendor qualification, and corrective and preventive actions (CAPA).