FDA Inspection
Novarad CorporationNovarad Corporation – FDA Inspection, Mar 30, 2016
Record Details
This FDA Inspection record concerns Novarad Corporation, with an inspection on March 30, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Novarad Corporation
- Inspection Date
- March 30, 2016
- Product Type
- Devices
View Company Profile
ID · 9600a0ac-0867-44e8-9e1b-c7a3ae4499c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 970063
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 806.10(c)(11)Domestic & foreign consignees
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Other FDA inspections of Novarad Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 2, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Novarad Corporation
- FDA Inspection 823986 - 2013-03-11
- FDA Inspection 653061 - 2010-04-02
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