FDA 483 - MEDLINE INDUSTRIES, LP - Northfield - August 29, 2025

Medline Industries, LP, a medical device manufacturer in Northfield, IL, received a Form FDA 483 citing significant quality system deficiencies. The inspection revealed inadequate corrective and preventive action procedures, insufficient control over purchased products, and failures in Medical Device Report (MDR) submission for serious injuries, including a death. Additionally, the firm's complaint handling and nonconforming product control processes were found to be deficient, leading to multiple product recalls and patient safety concerns.