FDA Inspection
Haven Innovation, Inc.Haven Innovation, Inc. – FDA Inspection, Nov 12, 2014
Record Details
This FDA Inspection record concerns Haven Innovation, Inc., with an inspection on November 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Haven Innovation, Inc.
- Inspection Date
- November 12, 2014
- Product Type
- Devices
View Company Profile
ID · 3420db52-4f86-4a9f-82cc-9732003c56e5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 902887
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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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 |
| March 27, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 2, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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