FDA WARNING_LETTER - Aionex Inc - November 20, 2012

An FDA inspection of Aionex Inc. in November 2012 revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) for their Class II Nurse Call and Class I Focus software medical devices. The inspection found the devices adulterated under Section 501(h) of the Act due to non-conformity with Current Good Manufacturing Practice requirements. The firm failed to respond to the FDA 483. Key deficiencies include the absence of Medical Device Reporting (MDR) procedures (21 CFR 803.17), inadequate complaint handling (21 CFR 820.198(a)), and a complete lack of procedures for quality audits (21 CFR 820.22), purchasing controls (21 CFR 820.50), and corrective and preventive actions (CAPA) (21 CFR 820.100(a)). Furthermore, the firm lacked essential design controls (21 CFR 820.30(a)(1)), Design History Files (DHF) (21 CFR 820.30(j)), Device Master Records (DMRs) (21 CFR 820.181), and Device History Records (DHRs) (21 CFR 820.184). Management also failed to conduct quality system reviews (21 CFR 820.20(c)), establish training procedures (21 CFR 820.25(b)), or define a quality policy (21 CFR 820.20(a)). Critically, Aionex Inc. lacks establishment registration and device listing, rendering their devices misbranded under Section 502(o) of the Act. The FDA requires a written response within 15 working days detailing corrective actions, prevention plans, and timelines. Failure to comply may result in severe regulatory actions, including seizure, injunction, civil penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments.