FDA Inspection
Cadence Science, Inc.Cadence Science, Inc. – FDA Inspection, Jan 25, 2017
Record Details
This FDA Inspection record concerns Cadence Science, Inc., with an inspection on January 25, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c6bf13ac-b4d1-445f-a0dc-eec09b9e0f6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998121
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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 |
| February 26, 2013 | 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 823932 - 2013-02-26
- FDA Inspection 713457 - 2011-03-04
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