FDA WARNING_LETTER - Ansar Group, Inc. d/b/a Ansar Medical Technologies, Inc - June 13, 2012

An FDA inspection of Ansar Group, Inc. (Ansar Medical Technologies, Inc.) from May 30 to June 13, 2012, found their ANX Version 3.0 Autonomic Nervous System Monitor adulterated and misbranded. The firm's late response to the FDA 483 was not reviewed. The device is adulterated under 21 U.S.C. § 351(h) due to widespread non-conformity with Quality System (QS) regulation (21 CFR Part 820). Deficiencies include inadequate design controls (plans, input, output, verification, validation, changes, DHF), purchasing controls, finished device acceptance, equipment calibration, complaint handling, management review, quality audits, and personnel training. The device is also misbranded under 21 U.S.C. § 352(t)(2) for failing to comply with Medical Device Reporting (21 CFR Part 803) and Reports of Corrections and Removals (21 CFR Part 806) requirements, specifically lacking written MDR procedures and failing to report a critical device component correction/removal. Furthermore, Ansar Group is promoting and marketing the ANX Version 3.0 for unapproved uses without required marketing clearance or approval. Significant changes to the device's intended use and technology were implemented without new 510(k) notification or PMA, resulting in adulteration under 21 U.S.C. § 351(f)(1)(B) and misbranding under 21 U.S.C. § 352(o). Unsubstantiated labeling claims also risk misbranding under 21 U.S.C. § 352(a). The FDA demands immediate cessation of marketing for unapproved uses and prompt correction of all violations. A comprehensive written response, including corrective actions, prevention plans, documentation, and a timetable, is required within fifteen business days. Non-compliance may lead to severe regulatory actions, including seizure, injunction, civil money penalties, and adverse impacts on business operations and future approvals.