FDA 483 - MEDLINE INDUSTRIES, LP - Northfield - April 06, 2022

During an inspection, Medline Industries, LP in Northfield, IL, was cited for significant deficiencies in its corrective and preventive action (CAPA) procedures. The firm's CAPA Review Board approved the closure of several CAPAs that were later found to be inadequate, leading to recalls of potentially non-sterile medical devices and issues with post-sterilization package seal integrity. These failures indicate a systemic problem in addressing root causes, ensuring personnel qualification, and validating critical manufacturing processes.