FDA Inspection
Haven Innovation, Inc.Haven Innovation, Inc. – FDA Inspection, Dec 17, 2015
Record Details
This FDA Inspection record concerns Haven Innovation, Inc., with an inspection on December 17, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Haven Innovation, Inc.
- Inspection Date
- December 17, 2015
- Product Type
- Devices
View Company Profile
ID · 4b9bcb3d-1037-4874-bd44-d9daa7927176
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 952747
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 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 820.22Quality Audits - defined intervals
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Haven Innovation, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2014 | OAI | 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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