FDA Inspection
Cadence Science, Inc.Cadence Science, Inc. – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns Cadence Science, Inc., with an inspection on September 13, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2398d0f1-d79a-4e46-87a1-e6fb6e18b8ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101982
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.53(a)Failure to Submit 5 Day Report
- 21 CFR 806.10(a)(1)Report of risk to health
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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 |
| January 25, 2017 | VAI | Center for Devices and Radiological Health | Compliance: 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 998121 - 2017-01-25
- FDA Inspection 823932 - 2013-02-26
- FDA Inspection 713457 - 2011-03-04
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