FDA 483 - Fagron, Inc - April 10, 2019

An FDA inspection of Fagron, Inc. in Saint Paul, MN, a manufacturer and repackager, revealed two significant observations related to quality control. The firm was cited for not having written responsibilities and procedures for its quality control unit, and for lacking a final approval process for Certificates of Analysis accompanying repackaged and distributed products. These findings indicate deficiencies in the firm's quality management system.