FDA Inspection
Medtronic Navigation, Inc.-BoxboroughMedtronic Navigation, Inc.-Boxborough – FDA Inspection, Jan 3, 2018
Record Details
This FDA Inspection record concerns Medtronic Navigation, Inc.-Boxborough, with an inspection on January 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a24959f6-76ec-4e3a-9446-4f8819c0ffd0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1036654
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
- 21 CFR 1002.20(a)Failure to report
- 21 CFR 1002.13Failure to submit
- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1002.30(a)(2)Results of tests
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medtronic Navigation, Inc.-Boxborough
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2024 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 17, 2016 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 11, 2013 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 26, 2011 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 15, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medtronic Navigation, Inc.-Boxborough
- FDA Inspection 1240926 - 2024-06-11
- FDA Inspection 963291 - 2016-03-17
- FDA Inspection 848319 - 2013-09-11
- FDA Inspection 746701 - 2011-09-26
- FDA Inspection 667059 - 2010-06-15
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