FDA WARNING_LETTER - Sam-Go Products - March 15, 2011

An FDA inspection of Sam-Go Products (March 8-15, 2011) found their Nex-Gen Clear Surgical Masks and Nex-Gen Respirator Masks adulterated and misbranded. The devices are adulterated under 501(h) due to extensive non-compliance with Quality System (QS) regulation (21 CFR Part 820). This includes failures in design control, purchasing, acceptance activities, complaint handling, nonconforming product procedures, management review, quality audits, design plans, Device Master Records, Device History Records, and distribution records. The devices are misbranded under 502(t)(2) for lacking Medical Device Reporting (MDR) procedures (21 CFR 803.17). Misbranding under 502(o) also stems from incorrect firm registration (repacker/relabeler) and failure to list manufactured devices. Furthermore, the masks are adulterated under 501(f)(1)(B) and misbranded under 502(o) because the firm modified a bacterial filter to create new devices without required Premarket Approval (PMA), Investigational Device Exemption (IDE), or 510(k) clearance. The Nex-Gen Respirator Mask is also misbranded under 502(b) for failing to include the manufacturer's place of business on its label (21 CFR 801.1). The firm's response to the FDA 483 was inadequate, lacking specific corrective actions, documentation, and timelines. Sam-Go Products must promptly correct all violations. Non-compliance could lead to regulatory actions like seizure, injunction, civil money penalties, and affect federal contracts or device approvals. A detailed written response with corrective actions and a timetable is required within fifteen working days.