FDA 483 - Lake Region Medical an Integer Company - June 11, 2025

During an inspection conducted from June 4 to June 11, 2025, Lake Region Medical, an Integer Company, received an FDA Form 483 citing significant issues related to their equipment maintenance practices. The primary observation highlighted that schedules for the adjustment, cleaning, and other maintenance of critical manufacturing equipment, specifically braiding machines and furnaces used in the production of MicroStent Peripheral Stent System components, were not adequately established or adhered to. The FDA investigator noted discrepancies in preventative maintenance records, demonstrating that staff failed to implement or follow established procedures. Several instances of overdue preventative maintenance for both braiding machines and furnaces were identified, with delays ranging from 63 to 102 days. Despite these unperformed or delayed maintenance activities, batch records indicated that the equipment was actively used to manufacture MicroStent products. The company's assertion that maintenance was not required when equipment was not in use was found to be inconsistent with their documented procedures. This situation indicates a failure to ensure that manufacturing equipment is suitable for its intended use, a fundamental requirement under the FDA's Quality System Regulation for medical devices. The company has indicated a plan to address these observations within 120 days by implementing corrective actions.