FDA WARNING_LETTER - ARJ Medical, Inc. - March 09, 2010

ARJ Medical, Inc., a specification developer of Urinalysis Reagent Strips, received an FDA Warning Letter following a March 2010 inspection. The inspection found their devices adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. 352(t)(2) for failing to furnish required information under Medical Device Reporting (MDR) regulation (21 CFR Part 803). Key QS violations included the lack of procedures for corrective and preventive actions (21 CFR 820.100(a)), complaint handling (21 CFR 820.198(a)), purchasing controls (21 CFR 820.50), design controls (21 CFR 820.30(a)(1)), and a defined quality policy (21 CFR 820.20(a)). Additionally, the firm failed to develop and implement written MDR procedures (21 CFR 803.17). The FDA also noted that ARJ Medical was marketing Sure Response Pregnancy Test and Quick Response Drug Screen without marketing clearance or approval, rendering them adulterated (21 U.S.C. 351(f)(1)(8)) and misbranded (21 U.S.C. 352(o)) due to lack of PMA/IDE approval, establishment registration, and 510(k) notification. The firm's response to the FDA 483 was deemed inadequate. ARJ Medical must provide a written response within 15 working days detailing corrective actions, a prevention plan, and a timetable for completion, or face potential regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts and device approvals.