FDA Inspection
C-RAD POSITIONING ABC-RAD POSITIONING AB – FDA Inspection, Jul 19, 2018
Record Details
This FDA Inspection record concerns C-RAD POSITIONING AB, with an inspection on July 19, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a772509a-bf6b-4427-bc7a-24e93d8fae8e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1059712
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1002.13Failure to submit
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(c)Investigation of device failures
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