FDA Inspection
NovoSci CorporationNovoSci Corporation – FDA Inspection, Apr 7, 2009
Record Details
This FDA Inspection record concerns NovoSci Corporation, with an inspection on April 7, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- NovoSci Corporation
- Inspection Date
- April 7, 2009
- Product Type
- Devices
View Company Profile
ID · 764a3b0d-4365-4b6c-8086-c83d3d19ef98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 576051
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(b)(1)Documentation of disposition, justification, signature
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Other FDA inspections of NovoSci Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2025 | Not classified | Dallas District Office | |
| November 7, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 7, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 26, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for NovoSci Corporation
- FDA Inspection 1286196 - 2025-09-09
- FDA Inspection 1109088 - 2019-11-07
- FDA Inspection 1019241 - 2017-06-07
- FDA Inspection 919681 - 2015-03-26
- FDA Inspection 766518 - 2012-01-26
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