FDA Inspection
Advanced MicroVas II, LLCAdvanced MicroVas II, LLC – FDA Inspection, Nov 18, 2013
Record Details
This FDA Inspection record concerns Advanced MicroVas II, LLC, with an inspection on November 18, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Advanced MicroVas II, LLC
- Inspection Date
- November 18, 2013
- Product Type
- Devices
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ID · f75d1c01-f520-4c64-951a-73e247ce8baa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 855597
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Advanced MicroVas II, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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