FDA Inspection
Kedrion S.p.A.Kedrion S.p.A. – FDA Inspection, Jun 24, 2022
Record Details
This FDA Inspection record concerns Kedrion S.p.A., with an inspection on June 24, 2022, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Kedrion S.p.A.
- Inspection Date
- June 24, 2022
- Product Type
- Biologics
View Company Profile
ID · fbe0aa0b-9fe7-401a-b552-fcbc4a5b8883
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1173210
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kedrion S.p.A.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2025 | Not classified | Office of Inspections and Investigations | |
| August 28, 2024 | Not classified | Office of Inspections and Investigations | |
| September 16, 2016 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 27, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 18, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Kedrion S.p.A.
- FDA Inspection 1281078 - 2025-04-10
- FDA Inspection 1254229 - 2024-08-28
- FDA Inspection 990289 - 2016-09-16
- FDA Inspection 907163 - 2014-06-27
- FDA Inspection 785499 - 2012-04-18
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