FDA WARNING_LETTER - Medline Industries, LP - January 22, 2024

On March 18, 2024, the FDA issued a Warning Letter to Medline, following an inspection from December 11, 2023, to January 22, 2024. The inspection found that Medline, a specification developer and complaint file establishment for syringes, needles, and sterile convenience kits, was distributing unapproved and misbranded devices.

Specifically, numerous Medline and Jiangsu Shenli Medical Production Co. Ltd. piston syringes, including those in convenience kits, were found to be adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act. Medline lacked premarket approval (PMA) or investigational device exemption (IDE) for these devices and failed to submit premarket notifications (510(k)). The FDA identified significant changes to cleared syringes (K103830), such as different sizes, luer slip tips, specific drug indications, colors, and control syringe types, which were not cleared and could affect safety and effectiveness, potentially causing inaccurate dosing, leaks, needle detachment, and adverse health effects from color additives. Medline's response regarding supplier agreements and vendor audits was deemed inadequate, as it did not confirm appropriate clearance or commit to recalling violative syringes already on the market or in transit.

Additionally, the inspection revealed Quality System regulation violations (21 CFR Part 820