FDA EIR - Medtronic MiniMed, Inc. - March 24, 2017

An FDA inspection was conducted at Medtronic MiniMed, Inc. in Northridge, CA, from March 7 to March 24, 2017. The inspection focused on the company's medical device manufacturing, particularly the Paradigm Real-Time Revel infusion pump system, under a Postmarket Inspection request for Class II and III devices. The regulatory framework covered included aspects of the Quality System Regulation (21 CFR 820), specifically reviewing Corrective & Preventive Action (CAPA) and Production & Process Controls subsystems. The inspection revealed significant deficiencies, documented in an FDA Form 483, primarily related to the acceptance of incoming products. Key violations included the inadequate establishment and adherence to procedures for incoming product acceptance. This involved automatically releasing numerous lots of molded polycarbonate sleeves and sterile infusion sets for production without required inspection, issuing Certificates of Conformance without actual testing, and a lack of proper documentation for accepted materials. Issues also arose from early electronic release of materials before inspection completion, missing Acceptable Quality Level (AQL) specifications, and the inability to locate certain lots designated for quality inspection. Additionally, management discussions highlighted that product hold orders were not implemented promptly for nonconforming items, bicarbonate buffer sensor testing procedures were incomplete, and device history records for infusion sets lacked comprehensive acceptance documentation. In response, James R. Dabbs, Vice President of Quality Assurance, acknowledged the observations, promised to correct all identified issues, and committed to submitting a written response to the FDA within 15 business days.