FDA Inspection
SIS Magnum Diamond, LLCSIS Magnum Diamond, LLC – FDA Inspection, Jun 9, 2010
Record Details
This FDA Inspection record concerns SIS Magnum Diamond, LLC, with an inspection on June 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SIS Magnum Diamond, LLC
- Inspection Date
- June 9, 2010
- Product Type
- Devices
View Company Profile
ID · 8779d50e-4b47-4e3c-b04d-3e9ffd01442f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 675126
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(h)Use and removal, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
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Other FDA inspections of SIS Magnum Diamond, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SIS Magnum Diamond, LLC
- FDA Inspection 781810 - 2012-05-10
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