FDA 483 - Minnesota MedTec, Inc. - December 11, 2019

An FDA inspection of Minnesota MedTec, Inc., a medical device contract manufacturer in Maple Grove, MN, revealed significant deficiencies in their quality system. Observations included inadequate training procedures for production operators, a failure to adequately establish corrective and preventive actions, and a lack of proper procedures for receiving and evaluating customer complaints. These issues indicate systemic problems in maintaining product quality and compliance.