FDA Inspection
R82 A/SR82 A/S – FDA Inspection, Nov 1, 2018
Record Details
This FDA Inspection record concerns R82 A/S, with an inspection on November 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f25bf9f4-63b7-4a3e-ab0e-8a1332b8bd5d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070529
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.200(d)Service reports
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
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Other FDA inspections of R82 A/S
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 7, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for R82 A/S
- FDA Inspection 839344 - 2013-06-07
- FDA Inspection 697737 - 2010-10-07
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