FDA WARNING_LETTER - Lucky Board Manufacturing - March 13, 2013

This FDA Warning Letter, issued June 20, 2013, to San Huei United Co. Ltd., resulted from a March 2013 inspection of their Shenzhen, China facility. The inspection found surgical masks to be adulterated and misbranded. Devices were adulterated under section 501(h) for non-conformity with Quality System (QS) regulation (21 CFR Part 820). QS violations included failures in process validation (21 CFR 820.75(a)), establishing corrective and preventive action procedures (21 CFR 820.100(a)(2)), maintaining complaint handling procedures (21 CFR 820.198(a)), controlling production processes (21 CFR 820.70(a)), and ensuring suitability of inspection and test equipment (21 CFR 820.72(a)). The devices were also misbranded under section 502(t)(2) for lacking written Medical Device Reporting (MDR) procedures (21 CFR 803.17). Further, the surgical masks were adulterated under section 501(f)(1)(B) due to the absence of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE), and misbranded under section 502(o) for failure to submit a 510(k) premarket notification. The FDA requires a written response within fifteen business days detailing specific corrective and preventive actions, including a timetable. Non-compliance may lead to refusal of admission for products (detention without physical examination), impact on federal contracts, and denial of PMA applications or Certificates to Foreign Governments. The firm must investigate and correct all violations.