FDA WARNING_LETTER - Cardinal Health - December 20, 2023

On December 11-20, 2023, an FDA inspection of Cardinal Health 200, LLC in Waukegan, Illinois, identified significant violations. The firm, an importer/distributor of Monoject™ Luer-lock tip and Enteral Feeding Syringes, received a Warning Letter dated April 24, 2024, following responses to a Form FDA 483.

The firm is marketing convenience kits containing Jiangsu Shenli Medical Production Co. Ltd. piston syringes (3 mL, 10 mL, 20 mL) and control syringes under K103830. This is an unapproved device violation because K103830 only cleared a 5cc Luer Lock piston syringe. These devices are adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act, as no premarket approval or 510(k) notification was submitted for these substantially different syringes, which could alter safety and effectiveness, potentially causing inaccurate dosing or leaks.

Additionally, the firm violated Quality System Regulation (21 CFR Part 820), specifically 21 CFR 820.50, for failing to adequately establish and maintain procedures for purchased product conformity. Procedure QS00015426, "Manufacturing Concept Sample Inspection," did not require review of data