FDA Inspection
Cambridge Heart, Inc.Cambridge Heart, Inc. – FDA Inspection, Mar 3, 2011
Record Details
This FDA Inspection record concerns Cambridge Heart, Inc., with an inspection on March 3, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cambridge Heart, Inc.
- Inspection Date
- March 3, 2011
- Product Type
- Devices
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ID · 3dd3ec83-d2d4-40a3-9e97-75295873fe71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 712247
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.50(b)Approval, inadequate purchasing data
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Other FDA inspections of Cambridge Heart, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 18, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cambridge Heart, Inc.
- FDA Inspection 820830 - 2013-03-04
- FDA Inspection 572842 - 2009-03-18
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