FDA 483 - Medline Industries, Inc - May 22, 2018

An FDA inspection of Medline Industries, Inc.'s Control Laboratory in Mundelein, IL, revealed two observations. The firm lacked appropriate controls over computer systems to prevent unauthorized data deletion and did not have procedures for reviewing audit trails. Additionally, laboratory controls were found to be deficient, specifically regarding a test method used for stability testing that did not specify the calculation of unspecified impurities.