FDA WARNING_LETTER - Baxter Healthcare Corporation

The FDA issued a Warning Letter to Baxter Healthcare Corporation concerning its SIGMA Spectrum Infusion Pump with Master Drug Library, identifying it as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The firm was previously informed in September 2012 that its (b)(4) for the device (b)(4), and subsequent communications confirmed the firm (b)(4). As a result, the device is deemed adulterated under section 501(f)(1)(B) of the Act because Baxter lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. Additionally, the device is misbranded under section 502(o) of the Act and 21 C.F.R. 807.81(a)(3)(i) for failing to notify the agency of its intent to introduce the modified device into commercial distribution, as required by section 510(k). Baxter Healthcare must submit a written response within fifteen working days, detailing corrective actions and preventative measures. Failure to promptly address these violations may lead to regulatory actions, including seizure, injunction, civil money penalties, and impact on federal contracts. The letter underscores the firm's responsibility for ensuring compliance with all applicable FDA regulations.