FDA WARNING_LETTER - Jiangsu Shenli Medical Production Co., Ltd. - March 19, 2024

The FDA issued a Warning Letter to Jiangsu Shenli Medical Production Co. Ltd. for marketing piston syringes in the U.S. without required marketing clearance or approval. The firm's products, including various sizes, luer slip/lock configurations, specific drug indications, and colors, are deemed adulterated under section 501(f)(1)(B) of the Act because they lack an approved premarket approval (PMA) or investigational device exemption (IDE).

The devices are also misbranded under section 502(o) for introducing devices with major changes or modifications to intended use or design that significantly affect safety or effectiveness without submitting a premarket notification (510(k)). Specifically, changes in syringe volume, tip type (luer lock to luer slip), and conversion to control syringes, as well as the addition of color additives and specific drug labeling, were identified as significant modifications. These changes pose risks such as inaccurate dosing, device leakage, needle detachment, allergic reactions, and organ toxicity.

The FDA noted postmarket safety signals, including customer complaints of cracks and breakage. The firm is requested to cease all activities resulting in misbranding or adulteration of the listed syringe configurations and to provide a written response within fifteen business days detailing corrective actions, a prevention plan, and a timetable for implementation. The implicated devices are subject to refusal of admission into the U.S.