FDA WARNING_LETTER - Taewoong Medical Co., Ltd. - July 31, 2014

An FDA inspection of Taewoong Medical Co., Ltd. in Gyeonggi-Do, Republic of Korea, from July 28-31, 2014, revealed significant violations concerning their Niti-S Biliary and Esophageal stents. The devices were deemed misbranded under 21 U.S.C. § 352(t)(2) due to failures in Medical Device Reporting (MDR) and nonconformances with Quality System (QS) regulations (21 CFR Part 820).

Key violations include the firm's failure to submit MDR reports for death or serious injury events within 30 calendar days, as required by 21 CFR 803.50(a)(1), citing instances of patient death from aortic perforation and serious injury from stent fracture. Additionally, the firm failed to establish and maintain procedures for reviewing and investigating device complaints (21 CFR 820.198(c)) and for validating processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)).

The firm's responses, including a CAPA, were deemed inadequate due to lack of implementation evidence and submission of a Korean-language MDR procedure without translation. Taewoong Medical must provide a written response within fifteen business days detailing specific, systemic corrective actions, including documentation and a timetable, with all non-English documents translated. Failure to comply may impact federal contracts and indicates serious underlying issues in their manufacturing and quality management systems.