FDA Inspection
O-Two Medical Technologies, Inc.O-Two Medical Technologies, Inc. – FDA Inspection, Aug 4, 2011
Record Details
This FDA Inspection record concerns O-Two Medical Technologies, Inc., with an inspection on August 4, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 4, 2011
- Product Type
- Devices
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ID · 9f95ca7d-0056-4896-9ff4-a977b2b69565
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 737564
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of O-Two Medical Technologies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for O-Two Medical Technologies, Inc.
- FDA Inspection 553077 - 2008-12-11
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