FDA 483 - Medline Industries, LP - May 25, 2018

An FDA inspection of Medline Industries, Inc. in Hartland, WI, from May 22-25, 2018, revealed significant deficiencies in their manufacturing practices. Observations included inadequate environmental monitoring procedures, insufficient out-of-specification investigation processes, and a lack of appropriate controls over computer systems used for identity testing. These issues indicate a need for improved quality control and data integrity measures at the facility.