Barton-Carey Products, Inc. – FDA Warning Letter, Aug 10, 2012

An FDA inspection of Barton-Carey Products, Inc. (Maumee, OH) from August 6-10, 2012, revealed significant violations concerning their medical support stockings. The devices were adulterated under 21 U.S.C. 351(f)(1)(B) due to the absence of an approved premarket approval (PMA) or investigational device exemption (IDE). They were also misbranded under 21 U.S.C. 352(o) for failing to submit 510(k) notifications (21 C.F.R. 807.81(a)(3)(ii)) for new intended uses (e.g., marketing for all body parts, new treatments) and for a device modification (adding a zipper) (21 C.F.R. 807.81(a)(3)(i)). Further, the devices were adulterated under 21 U.S.C. 351(h) due to non-compliance with Quality System (QS) regulation (21 CFR Part 820). Deficiencies included inadequate procedures for corrective and preventive actions (21 CFR 820.100(a)), design changes (21 CFR 820.30(i)), complaint handling (21 CFR 820.198(a)-(c)), purchasing controls (21 CFR 820.50(b)), and failure to maintain a device master record with component specifications (21 CFR 820.181(a)). Additionally, the devices were misbranded under 21 U.S.C. 352(t)(2) for failing to furnish required Medical Device Reporting (MDR) information (21 CFR Part 803), specifically lacking adequate written MDR procedures (21 CFR 803.17). The firm's August 29, 2012, response, outlining future procedural revisions, was not assessable. Barton-Carey must promptly correct all violations and provide a detailed written response within fifteen working days, including corrective actions, prevention plans, documentation, and a timetable. Non-compliance could result in regulatory actions like seizure, injunctions, civil penalties, and impact federal contracts and device approvals.