FDA 483 - GEM City Enginnering and Manufacturing Corporation - March 01, 2018

GEM City Engineering and Manufacturing Corporation, a contract manufacturer in Dayton, OH, was cited for significant deficiencies across its quality system during an FDA inspection. The observations highlight systemic failures in document control, corrective and preventive actions, production processes, finished device acceptance, complaint handling, nonconforming product control, device history records, and process validation. These issues indicate a broad lack of established and followed procedures essential for ensuring device quality and regulatory compliance.