FDA Inspection
Medtronic Heart Valves DivisionMedtronic Heart Valves Division – FDA Inspection, Dec 19, 2008
Record Details
This FDA Inspection record concerns Medtronic Heart Valves Division, with an inspection on December 19, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 19, 2008
- Product Type
- Devices
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ID · 708623bf-33e9-4222-8a5b-45ec5bd58249
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 551423
- 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(a)(2)Investigation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 820.72(b)(2)Calibration documentation
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Other FDA inspections of Medtronic Heart Valves Division
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 30, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 9, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 3, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medtronic Heart Valves Division
- FDA Inspection 1131979 - 2020-10-26
- FDA Inspection 965285 - 2016-03-30
- FDA Inspection 917203 - 2015-03-09
- FDA Inspection 870529 - 2014-03-07
- FDA Inspection 850644 - 2013-09-03
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