FDA Inspection
DiaSorin S.p.A UK BranchDiaSorin S.p.A UK Branch – FDA Inspection, Feb 10, 2023
Record Details
This FDA Inspection record concerns DiaSorin S.p.A UK Branch, with an inspection on February 10, 2023, issued by the Office of Inspections and Investigations.
- Company
- DiaSorin S.p.A UK Branch
- Inspection Date
- February 10, 2023
View Company Profile
ID · 39b202a2-b8c2-462b-9f43-e02599d52d29
Inspection Facts
- Inspection number
- 1198109
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DiaSorin S.p.A UK Branch
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for DiaSorin S.p.A UK Branch
- FDA Inspection 1100469 - 2019-08-01
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.