FDA Inspection
Fidia Farmaceutici S.p.A.Fidia Farmaceutici S.p.A. – FDA Inspection, Sep 3, 2026
Record Details
This FDA Inspection record concerns Fidia Farmaceutici S.p.A., with an inspection on September 3, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Fidia Farmaceutici S.p.A.
- Inspection Date
- September 3, 2026
- Product Type
- Medical Devices & Rad Health
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ID · af605ab4-ccc7-4479-9e7c-a5cff553d36f
Inspection Facts
- Inspection number
- 1334416
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fidia Farmaceutici S.p.A.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2024 | Not classified | Office of Inspections and Investigations | |
| October 31, 2018 | Not classified | Office of Inspections and Investigations | |
| June 27, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| November 10, 2016 | NAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| November 14, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fidia Farmaceutici S.p.A.
- FDA Inspection 1260761 - 2024-12-09
- FDA Inspection 1108126 - 2018-10-31
- FDA Inspection 1018285 - 2017-06-27
- FDA Inspection 998561 - 2016-11-10
- FDA Inspection 905833 - 2014-11-14
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