# FDA WARNING_LETTER - Nuga Medical Co., Ltd. - August 28, 2014

Source: https://www.keypedia.com/records/warning_letter/nuga-medical-co-ltd/1fa34991-0376-49e9-b71f-89fa51adc4e0

> FDA WARNING_LETTER for Nuga Medical Co., Ltd. on August 28, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nuga Medical Co., Ltd.
- Inspection Date: 2014-08-28
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.keypedia.com/companies/nuga-medical-co-ltd/0cf1dd61-d88d-4cfe-b1fb-447cd38d59bc

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7