FDA Inspection
Cadence Science, Inc.Cadence Science, Inc. – FDA Inspection, Feb 26, 2013
Record Details
This FDA Inspection record concerns Cadence Science, Inc., with an inspection on February 26, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cadence Science, Inc.
- Inspection Date
- February 26, 2013
- Product Type
- Devices
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ID · 6ca3b080-6cae-4c63-93ad-318702dcd9a7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823932
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Lack of procedures, or not maintained
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Other FDA inspections of Cadence Science, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 13, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 25, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 4, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cadence Science, Inc.
- FDA Inspection 1192001 - 2022-11-29
- FDA Inspection 1101982 - 2019-09-13
- FDA Inspection 998121 - 2017-01-25
- FDA Inspection 713457 - 2011-03-04
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