FDA 483 - Mcminnville Workholding Company, Inc. - June 03, 2022

An FDA inspection of Mcminnville Workholding Company, Inc. in McMinnville, TN, a medical device manufacturer, revealed significant deficiencies in record retention and document control procedures. The firm failed to maintain required records for devices released for commercial distribution and did not adequately establish procedures for managing changes to documents, leading to incomplete revision histories.