FDA Inspection
Sorin Group Italia S.r.l.Sorin Group Italia S.r.l. – FDA Inspection, Jan 21, 2016
Record Details
This FDA Inspection record concerns Sorin Group Italia S.r.l., with an inspection on January 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sorin Group Italia S.r.l.
- Inspection Date
- January 21, 2016
- Product Type
- Devices
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ID · e837152d-fa34-492c-a05c-9f6dfba83e6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 956374
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Sorin Group Italia S.r.l.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2026 | Not classified | Office of Inspections and Investigations | |
| February 15, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Sorin Group Italia S.r.l.
- FDA Inspection 1329636 - 2026-07-09
- FDA Inspection 1079012 - 2018-02-15
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