FDA 483 - Medegen Medical Products, LLC - October 10, 2019

An FDA inspection of Medegen Medical Products, LLC in Gallaway, TN, a medical device manufacturer, revealed significant deficiencies in their quality management system. Observations included inadequate process validation for sharps containers and specimen collection cups, ineffective corrective and preventive actions, and insufficient procedures for finished device acceptance. The firm also failed to adequately control non-conforming products and maintain complete device history records.