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Medline Industries was cited for distributing unapproved sterile syringes and convenience kits without required premarket approval (PMA) or 510(k) notification, rendering the products adulterated and misbranded under federal law. An FDA inspection of the company's Illinois facility from December 2023 through January 2024 identified that Medline syringes and Jiangsu Shenli Medical Production Co. Ltd. piston syringes of various sizes lacked the necessary regulatory authorizations for commercial distribution. The company failed to comply with section 515(a) and section 510(k) requirements, which mandate either approved PMA applications or proper premarket notification before introducing Class III devices into commerce.