FDA Inspection
Carrio Cabling CorporationCarrio Cabling Corporation – FDA Inspection, Oct 27, 2023
Record Details
This FDA Inspection record concerns Carrio Cabling Corporation, with an inspection on October 27, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7963ef55-368e-4e4e-b420-c78b073f4f87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221233
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Carrio Cabling Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Carrio Cabling Corporation
- FDA Inspection 950177 - 2015-11-17
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