FDA Inspection
Intraop Medical CorporationIntraop Medical Corporation – FDA Inspection, Oct 6, 2011
Record Details
This FDA Inspection record concerns Intraop Medical Corporation, with an inspection on October 6, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Intraop Medical Corporation
- Inspection Date
- October 6, 2011
- Product Type
- Devices
View Company Profile
ID · f1445d24-82d2-4d69-8f62-20451270653b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749347
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
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Other FDA inspections of Intraop Medical Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Intraop Medical Corporation
- FDA Inspection 1017184 - 2017-05-25
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