FDA WARNING_LETTER - NeoChild LLC - May 01, 2008

An FDA inspection of NeoChild LLC in Oklahoma City, OK, from April 17 to May 1, 2008, revealed that the firm's manufactured devices, including the SafeChild System and various catheters/trays, are adulterated under section 501(h) of the Act. This is due to non-conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm's May 15, 2008, response to the FDA 483 was largely inadequate.

Significant QS regulation violations include failures to establish and maintain procedures for quality audits (820.22), design control (820.30(a),(b)), design validation (820.30(g)), design reviews (820.30(e)), design transfer (820.30(h)), design change control (820.30(i)), and device design history files (820.30(j)). Further deficiencies involved purchasing controls (820.50), acceptance activities (820.80), device history records (820.184), and complaint handling (820.198).

Additionally, the firm's devices are misbranded under section 502(t)(2) for failing to implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17), though a corrective action was noted as adequate but unverified. The SafeChild System enteral feeding tubes and extension sets are also adulterated under section 501(f)(1)(B) and misbranded under section 502(o) due to the lack of an approved pre-market approval (PMA) or investigational device exemption (IDE) and failure to submit a 510(k) notification. NeoChild LLC must promptly correct these violations, provide a written response within 15 working days detailing corrective actions and a timetable, or face potential regulatory actions including seizure, injunction, and civil penalties, impacting federal contracts and device approvals.