EUROSIREL SPA
FDA inspection history in Cusago, Italy, 2024
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One warning letter and one Form 483, at Cusago, Italy.
Cited most
Across all EUROSIREL SPA observations on file
- 21 CFR 211.101Charge-in of components1
- 21 CFR 211.125Labeling issuance1
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete EUROSIREL SPA file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Cusago, Italy
One warning letter, one Form 483 and one close-out letter · 2024 · 5 observations
Latest: Warning letter, Nov 20, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-20 | Warning letter Warning letter | Cusago, Italy | — | $99 |
| 2024-05-24 | 483 Form 483 | Cusago, Italy | 5 | $99 |
| Undated | Close-out Close-out letter | Cusago, Italy | — | $99 |
FEI number 3015892095 · most recent document Nov 20, 2024
About EUROSIREL SPA
How many FDA Form 483s has EUROSIREL SPA received?
FDA Intel has 1 Form 483 on file for EUROSIREL SPA; the most recent is dated May 24, 2024.
When was EUROSIREL SPA last inspected by FDA?
The most recent FDA inspection document on file for EUROSIREL SPA is a Form 483 dated May 24, 2024, for the site in Cusago, Italy.
What did FDA cite at EUROSIREL SPA?
The regulations cited most in the observations on file for EUROSIREL SPA are 21 CFR 211.101 (Charge-in of components), 1 time; 21 CFR 211.125 (Labeling issuance), 1 time; 21 CFR 211.182 (Equipment cleaning and use log), 1 time.
Has EUROSIREL SPA received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for EUROSIREL SPA; the most recent is dated Nov 20, 2024.