FDA Inspection
A3R, LlcA3R, Llc – FDA Inspection, Apr 10, 2019
Record Details
This FDA Inspection record concerns A3R, Llc, with an inspection on April 10, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e3781843-9971-4091-bbc7-3d1929af3a3e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1086408
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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