FDA Inspection
Medtronic Monitoring Inc.Medtronic Monitoring Inc. – FDA Inspection, Oct 23, 2009
Record Details
This FDA Inspection record concerns Medtronic Monitoring Inc., with an inspection on October 23, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic Monitoring Inc.
- Inspection Date
- October 23, 2009
- Product Type
- Devices
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ID · d9ce8b3d-21bc-4828-b83b-d7b89fbc7d5a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 626767
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.100(a)(5)Implementing changes
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(f)Design verification - unresolved discrepancies
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Other FDA inspections of Medtronic Monitoring Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 22, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medtronic Monitoring Inc.
- FDA Inspection 1042090 - 2017-12-14
- FDA Inspection 781222 - 2012-05-22
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