FDA Inspection
Cranial SolutionsCranial Solutions – FDA Inspection, May 14, 2010
Record Details
This FDA Inspection record concerns Cranial Solutions, with an inspection on May 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cranial Solutions
- Inspection Date
- May 14, 2010
- Product Type
- Devices
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ID · c8006e35-e984-4933-9aa8-a9237f3a8068
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 662534
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(a)Lack of or inadequate procedures
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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 |
| January 21, 2011 | 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 709427 - 2011-01-21
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