FDA Inspection
Mizuho OSIMizuho OSI – FDA Inspection, Sep 11, 2012
Record Details
This FDA Inspection record concerns Mizuho OSI, with an inspection on September 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mizuho OSI
- Inspection Date
- September 11, 2012
- Product Type
- Devices
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ID · c72d4157-e362-48b9-930e-6b94db00e0ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 798286
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Mizuho OSI
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 2, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Mizuho OSI
- FDA Inspection 968511 - 2016-02-25
- FDA Inspection 850919 - 2013-09-25
- FDA Inspection 661263 - 2010-06-02
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