FDA Inspection
Medtronic Navigation, Inc.-BoxboroughMedtronic Navigation, Inc.-Boxborough – FDA Inspection, Mar 17, 2016
Record Details
This FDA Inspection record concerns Medtronic Navigation, Inc.-Boxborough, with an inspection on March 17, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 17, 2016
- Product Type
- Devices
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ID · fea63321-b621-43a4-95f0-7b358823ef45
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 963291
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
7- 21 CFR 1020.30(d)(1)Report of assembly submitted within 15 days
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 1003.21(a)Incomplete notification of affected persons
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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 |
| January 3, 2018 | 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 1036654 - 2018-01-03
- FDA Inspection 848319 - 2013-09-11
- FDA Inspection 746701 - 2011-09-26
- FDA Inspection 667059 - 2010-06-15
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