483
ProMED Concepts, LLCProMED Concepts, LLC – FDA 483, Mar 3, 2025
Record Details
PROMED Concepts, LLC, a contract manufacturer in Brighton, TN, was inspected by the FDA from February 24 to March 3, 2025. The inspection revealed significant and repeat deficiencies in the firm's quality system, specifically regarding corrective and preventive action (CAPA) procedures and the handling of customer complaints. These issues indicate a systemic failure to adequately establish and maintain essential quality processes.
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