FDA WARNING_LETTER - Royal King Infant Products Co., Ltd. - May 03, 2012

An FDA inspection of Royal King Infant Products Co., Ltd. in Samutsakhon, Thailand, from April 30 to May 03, 2012, revealed that the firm's fluid-filled teething rings, classified as devices, are adulterated. The manufacturing methods, facilities, and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). Eleven distinct violations were identified, including failures in process validation (21 CFR 820.75(a)), corrective and preventive action procedures (21 CFR 820.100(a)), complaint handling and Medical Device Reporting (MDR) evaluation (21 CFR 820.198(a), 820.198(a)(3)), design control (requirements, verification, transfer, and reviews) (21 CFR 820.30(c), 820.30(f), 820.30(h), 820.30(e)), control of non-conforming products (21 CFR 820.90(a)), and maintaining Device History Records (DHRs) and Device Master Records (DMRs) (21 CFR 820.184, 820.181). The firm's response dated May 14, 2012, was deemed inadequate due to a lack of evidence for implementation, systemic corrective actions, training, or retroactive reviews. Consequently, the firm's products are subject to refusal of admission into the U.S. and may face detention without physical examination. The firm must provide a written response within fifteen business days detailing specific, documented corrective and preventive actions, including a timetable for completion, to address these serious violations.