FDA Inspection
DiaSorin S.p.A.DiaSorin S.p.A. – FDA Inspection, Jan 24, 2013
Record Details
This FDA Inspection record concerns DiaSorin S.p.A., with an inspection on January 24, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DiaSorin S.p.A.
- Inspection Date
- January 24, 2013
- Product Type
- Devices
View Company Profile
ID · ecdeda0c-f9df-43e4-99a4-9816acfde3a3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 820927
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)General
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DiaSorin S.p.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 11, 2019 | Not classified | Office of Inspections and Investigations | |
| May 13, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DiaSorin S.p.A.
- FDA Inspection 1199544 - 2023-02-06
- FDA Inspection 1092467 - 2019-04-11
- FDA Inspection 584985 - 2009-05-13
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