FDA Inspection
Cerapedics, Inc.Cerapedics, Inc. – FDA Inspection, Apr 2, 2010
Record Details
This FDA Inspection record concerns Cerapedics, Inc., with an inspection on April 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cerapedics, Inc.
- Inspection Date
- April 2, 2010
- Product Type
- Devices
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ID · fc155f2d-ff3a-4e94-b99b-f05ff7a33ca5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 655394
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Cerapedics, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2024 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| October 24, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 9, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 5, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 18, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Cerapedics, Inc.
- FDA Inspection 1233355 - 2024-03-13
- FDA Inspection 1107407 - 2019-10-24
- FDA Inspection 995653 - 2016-12-09
- FDA Inspection 929211 - 2015-06-05
- FDA Inspection 903948 - 2014-11-18
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