Nuga Medical Co., Ltd. – FDA Warning Letter, Aug 28, 2014

On December 24, 2014, the FDA issued a Warning Letter to Nuga Medical Co., Ltd. following an inspection from August 25-28, 2014, at their facility in Gwangju City, Republic of Korea. The inspection revealed that their therapeutic heating and massaging devices (NM-7000, NM-2500, NM-90) are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include: 1. **Design Control (21 CFR 820.30(g), (f), (i)):** Failure to establish and maintain procedures for design validation (e.g., no investigation of NM-7000 design validation failures), design verification (e.g., no procedures/reports for NM-7000 temperature shutdown, unqualified test equipment), and control of design changes (e.g., undocumented fuse change for NM-7000, un