Kedrion S.p.A.
FDA inspection history in Lucca, Italy, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Lucca, Italy.
Cited most
Across all Kedrion S.p.A. observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment1
The complete Kedrion S.p.A. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Lucca, Italy
One Form 483 · 2022 · 3 observations
Latest: Form 483, Jun 24, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-06-24 | 483 Form 483 | Lucca, Italy | 3 | $99 |
Investigators on these documents
FEI number 3008919567 · most recent document Jun 24, 2022
About Kedrion S.p.A.
How many FDA Form 483s has Kedrion S.p.A. received?
FDA Intel has 1 Form 483 on file for Kedrion S.p.A.; the most recent is dated Jun 24, 2022.
When was Kedrion S.p.A. last inspected by FDA?
The most recent FDA inspection document on file for Kedrion S.p.A. is a Form 483 dated Jun 24, 2022, for the site in Lucca, Italy.
What did FDA cite at Kedrion S.p.A.?
The regulations cited most in the observations on file for Kedrion S.p.A. are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.67(b) (Equipment cleaning and maintenance), 1 time; 21 CFR 211.68(a) (Automatic, mechanical, and electronic equipment), 1 time.