FDA Inspection
Cranial SolutionsCranial Solutions – FDA Inspection, Jan 21, 2011
Record Details
This FDA Inspection record concerns Cranial Solutions, with an inspection on January 21, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cranial Solutions
- Inspection Date
- January 21, 2011
- Product Type
- Devices
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ID · 18b0b2fa-4eeb-4184-b406-a3cd5a95a363
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 709427
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.198(e)Records of complaint investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cranial Solutions
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 14, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cranial Solutions
- FDA Inspection 1029549 - 2017-09-25
- FDA Inspection 778684 - 2012-04-20
- FDA Inspection 662534 - 2010-05-14
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