FDA 483 - ProMed Pharma, LLC - February 21, 2024

An FDA inspection of ProMed Pharma, LLC, a contract manufacturer of medical devices in Plymouth, MN, revealed a significant deficiency in their quality system. The firm failed to adequately establish corrective and preventive action (CAPA) procedures, specifically by not updating process failure modes and effects analysis (pFMEA) risk management documents as required. This included not addressing risks related to low humidity excursions and the use of incorrect adhesives in medical device manufacturing.