FDA Inspection
Inovise Medical, Inc.Inovise Medical, Inc. – FDA Inspection, Jun 1, 2011
Record Details
This FDA Inspection record concerns Inovise Medical, Inc., with an inspection on June 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Inovise Medical, Inc.
- Inspection Date
- June 1, 2011
- Product Type
- Devices
View Company Profile
ID · e03768b4-4f80-4a21-a20d-bc84daefcbe7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 727390
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.198(e)Records of complaint investigation
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Other FDA inspections of Inovise Medical, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 21, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Inovise Medical, Inc.
- FDA Inspection 933856 - 2015-06-12
- FDA Inspection 823440 - 2013-03-21
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