FDA Inspection
Haven Innovation, Inc.Haven Innovation, Inc. – FDA Inspection, May 2, 2012
Record Details
This FDA Inspection record concerns Haven Innovation, Inc., with an inspection on May 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Haven Innovation, Inc.
- Inspection Date
- May 2, 2012
- Product Type
- Devices
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ID · f4047567-a6e6-406d-bb39-7268d199abf3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781196
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Haven Innovation, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 12, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 27, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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