FDA Inspection
Nuga Medical Co., Ltd.Nuga Medical Co., Ltd. – FDA Inspection, Jul 27, 2018
Record Details
This FDA Inspection record concerns Nuga Medical Co., Ltd., with an inspection on July 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 20c3dfc8-3cca-4792-8a15-b54d81f01461
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060124
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.184DHR content
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Other FDA inspections of Nuga Medical Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 28, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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