Medline Industries, Inc – FDA 483, Jul 22, 2026

Medline Industries, LP, a laboratory in Mundelein, IL, received a Form 483 citing significant deficiencies in its quality control systems. Observations included inadequate laboratory controls for microbial testing media, issues with the accuracy and integrity of its LIMS computerized system, and a failure to follow established procedures for microbial risk assessments and deviation reporting. These issues indicate a lack of robust controls over critical laboratory processes and data, potentially compromising product quality and data reliability.