FDA Inspection
Quantum Medical Imaging, LLCQuantum Medical Imaging, LLC – FDA Inspection, Jul 31, 2014
Record Details
This FDA Inspection record concerns Quantum Medical Imaging, LLC, with an inspection on July 31, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Quantum Medical Imaging, LLC
- Inspection Date
- July 31, 2014
- Product Type
- Devices
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ID · 9eab7178-6d4a-4931-89de-bd350995d9a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 889573
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
2- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Quantum Medical Imaging, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 11, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Quantum Medical Imaging, LLC
- FDA Inspection 809210 - 2012-11-27
- FDA Inspection 651060 - 2010-03-11
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