Carematrix, Inc. – FDA Warning Letter, Mar 21, 2008

An FDA inspection of Carematix, Inc. (March 11-21, 2008) identified significant violations for its Carematix Wellness System. The firm was marketing the device for unapproved uses, including measuring PEFR/FEV and diagnosing asthma/COPD, which required a new 510(k) (21 CFR 807.81(a)(3)). This rendered the device adulterated (Section 501(f)(1)(B) of the Act) and misbranded (Section 502(o)). Additionally, nine violations of the Quality System (QS) regulation (21 CFR Part 820) were cited, leading to device adulteration under Section 501(h). These cGMP deficiencies included failures in: design verification (21 CFR 820.30(f)); comprehensive corrective and preventive actions (CAPA) for nonconformities (21 CFR 820.100(a)(3), 820.100(a)(5), 820.100(a)(2)); complaint handling, investigation, and MDR evaluation (21 CFR 820.198(c), 820.198(a)(3), 820.198(a)(1)); finished device acceptance (21 CFR 820.80(d)); supplier qualification (21 CFR 820.50(a)(1)); and personnel training (21 CFR 820.25(b)). Carematix's response to the FDA 483 was largely inadequate. FDA mandated immediate cessation of unapproved marketing and a 15-working-day written response detailing complete corrective actions and a timetable. Non-compliance risks severe regulatory actions, including seizure, injunction, civil money penalties, and impacts on federal contracts and device approvals.