FDA WARNING_LETTER - P.T. Sankei Medical Industries - May 11, 2023

An FDA inspection of JL. Mordern Inustri III in Banten, Indonesia, from May 8-11, 2023, revealed significant violations concerning their Sphygmomanometer Unit (Adult and Large Adult), Single Use, Latex Free device. The firm made material changes to a cleared device without submitting a new 510(k), rendering the device adulterated under 21 U.S.C. § 351(f)(1)(B) (lack of PMA/IDE) and misbranded under 21 U.S.C. § 352(o) (failure to notify agency of intent to market). The inspection also identified multiple Quality System Regulation (QSR) violations, indicating the device is adulterated under 21 U.S.C. § 351(h). These include failures in design controls (21 CFR 820.30(a)), purchasing controls (21 CFR 820.50), maintaining Design History Records (21 CFR 820.184) and Device Master Records (21 CFR 820.181), establishing adequate complaint handling procedures (21 CFR 820.198), and conducting quality audits (21 CFR 820.22). Additionally, the firm failed to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17), leading to misbranding under 21 U.S.C. § 352(t)(2). The firm's responses to the FDA 483 were deemed inadequate, often due to insufficient corrective actions or lack of English translations for supporting documents. The FDA requires a written response within fifteen business days detailing specific, systemic corrective actions, a timetable for implementation, and all documentation in English. Non-compliance may affect federal contracts and Class III device approvals.