FDA 483 - Medline Industries, Inc - July 10, 2023

An FDA inspection of Medline Industries, LP in Mundelein, IL, a control testing laboratory for drugs, revealed two significant observations. The firm was cited for inadequate written records of investigations into unexplained discrepancies and for a stability program that does not assure drug product testing in its marketed container-closure system. These issues suggest deficiencies in quality control and product stability assurance.