Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-10.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2025 – 10 Apr 2025 | Biologics | Clean | |
| 21 Aug 2024 – 28 Aug 2024 | Biologics | Clean | |
| 16 Jun 2022 – 24 Jun 2022 | Biologics | 483 | View 483 → |
| 8 Sep 2016 – 16 Sep 2016 | Biologics | 483 | On file |
| 19 Jun 2014 – 27 Jun 2014 | Biologics | 483 | On file |
| 18 Apr 2012 | Not recorded | 483 | On file |
| 2 Mar 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jun 2022
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Scott T Ballard, Lewis K Antwi
24 Jun 2022
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Scott T Ballard, Lewis K Antwi
Investigators
FDA investigators tied to this site in the record.
Malgorzata G Norton1 insp.
Erin C Hill1 insp.
Lisa T Pham1 insp.
Hector A Carrero1 insp.
Grace I Cortesini1 insp.
Scott T Ballard1 insp.
Lewis K Antwi1 insp.
Omotunde O Osunsanmi1 insp.
Jacqueline M Diaz Albert1 insp.
Paula A Trost1 insp.
Christian Lynch1 insp.
Lori P Peters1 insp.
Sean R Byrd1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kedrion S.p.A.'s 5 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat