FDA Inspection
Cadence Science, Inc.Cadence Science, Inc. – FDA Inspection, Mar 4, 2011
Record Details
This FDA Inspection record concerns Cadence Science, Inc., with an inspection on March 4, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cadence Science, Inc.
- Inspection Date
- March 4, 2011
- Product Type
- Devices
View Company Profile
ID · 124b9405-abfa-4f9d-868b-5117d136028e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 713457
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
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 |
| February 26, 2013 | 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 823932 - 2013-02-26
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