FDA Inspection
Mirion Technologies (Capintec), Inc.Mirion Technologies (Capintec), Inc. – FDA Inspection, Dec 8, 2010
Record Details
This FDA Inspection record concerns Mirion Technologies (Capintec), Inc., with an inspection on December 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 8, 2010
- Product Type
- Devices
View Company Profile
ID · 5a135f54-918e-4450-a23d-8a6d7ad8d421
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702065
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
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Other FDA inspections of Mirion Technologies (Capintec), Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2019 | Not classified | New Jersey District Office | |
| January 25, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 23, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Mirion Technologies (Capintec), Inc.
- FDA Inspection 1127776 - 2019-08-16
- FDA Inspection 960337 - 2016-01-25
- FDA Inspection 815182 - 2013-01-23
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