FDA Inspection
Advanced Radiation Measurement, Inc.Advanced Radiation Measurement, Inc. – FDA Inspection, Jun 6, 2016
Record Details
This FDA Inspection record concerns Advanced Radiation Measurement, Inc., with an inspection on June 6, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 6, 2016
- Product Type
- Devices
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ID · 87322b1a-7e36-46cc-baa6-ea17775f5356
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 973354
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Advanced Radiation Measurement, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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