FDA Inspection
Control-X Medical IncControl-X Medical Inc – FDA Inspection, Sep 9, 2019
Record Details
This FDA Inspection record concerns Control-X Medical Inc, with an inspection on September 9, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cad110d1-8fde-4d6d-b058-026465e779d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101568
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 1002.13Failure to submit
- 21 CFR 820.80(e)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Control-X Medical Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 20, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Control-X Medical Inc
- FDA Inspection 987075 - 2016-09-30
- FDA Inspection 720688 - 2011-04-20
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