FDA Inspection
Inovo, IncInovo, Inc – FDA Inspection, Nov 19, 2014
Record Details
This FDA Inspection record concerns Inovo, Inc, with an inspection on November 19, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Inovo, Inc
- Inspection Date
- November 19, 2014
- Product Type
- Devices
View Company Profile
ID · c51af29a-2145-4549-9776-fb6180d4e315
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 905359
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate 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 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of Inovo, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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