FDA WARNING_LETTER - Jiangsu JDC Medical Devices Co., Ltd. - September 19, 2019

An FDA inspection of Heng Yang Shi in Lianyungang, China, from September 16-19, 2019, found the firm's Bulb Tip Yankauer and Chemiluminated Vaginal Speculum devices adulterated under 21 U.S.C. § 351(h) for non-conformity with 21 CFR Part 820 Quality System regulations. The devices were also misbranded under 21 U.S.C. § 352(t)(2) due to inadequate Medical Device Reporting (MDR) procedures as required by 21 CFR Part 803. Key violations included the failure to establish and maintain adequate design control procedures (21 CFR 820.30(a)), develop and monitor production processes to ensure device conformity (21 CFR 820.70(a)), adequately control environmental conditions (21 CFR 820.70(c)), and control labeling activities (21 CFR 820.120). Additionally, the firm failed to implement written MDR procedures (21 CFR 803.17) for timely event identification, evaluation, reporting, and record-keeping. The firm's October 10, 2019, response was deemed largely inadequate. Consequently, the firm's devices are subject to refusal of admission into the U.S. (detention without physical examination). Heng Yang Shi must respond within fifteen business days with specific, systemic corrective actions, preventative measures, and a timetable, including an assessment of previously distributed nonconforming products. Untranslated documents must be provided in English. Failure to correct violations will impact federal contracts and Class III device premarket approvals.