FDA Inspection
Mediana Co., Ltd.Mediana Co., Ltd. – FDA Inspection, Jul 24, 2014
Record Details
This FDA Inspection record concerns Mediana Co., Ltd., with an inspection on July 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mediana Co., Ltd.
- Inspection Date
- July 24, 2014
- Product Type
- Devices
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ID · a1ffb41a-d5f9-41e8-83ff-d498c37eb4bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891395
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Mediana Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 9, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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