FDA 483 - Epien Medical, Inc - December 06, 2018

Epien Medical, Inc. in White Bear Lake, MN, was inspected from November 26, 2018, to December 6, 2018, and received a Form 483 with three observations. The observations highlight deficiencies in quality control for raw materials, including a failure to establish supplier reliability for Certificates of Analysis and a lack of incoming component identity testing. Additionally, the firm's equipment cleaning procedures were found to be inadequate, lacking evaluation of effectiveness and specific instructions.