FDA Inspection
Medtronic NeuromodulationMedtronic Neuromodulation – FDA Inspection, Jan 21, 2011
Record Details
This FDA Inspection record concerns Medtronic Neuromodulation, with an inspection on January 21, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic Neuromodulation
- Inspection Date
- January 21, 2011
- Product Type
- Devices
View Company Profile
ID · 8a39f081-82bb-4389-8f8c-32f11a1e12ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709624
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - production units
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medtronic Neuromodulation
15| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 3, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 9, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 6, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medtronic Neuromodulation
- FDA Inspection 1206222 - 2023-05-05
- FDA Inspection 1187313 - 2022-11-03
- FDA Inspection 1153966 - 2021-09-09
- FDA Inspection 1108789 - 2019-10-17
- FDA Inspection 1102180 - 2019-08-06
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