Alexion Pharma International Operations Limited
FDA inspection history in Dublin, Ireland, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Dublin, Ireland.
Cited most
Across all Alexion Pharma International Operations Limited observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.42Design and construction features1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Alexion Pharma International Operations Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Dublin, Ireland
One Form 483 · 2023 · 4 observations
Latest: Form 483, Jan 24, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-24 | 483 Form 483 | Dublin, Ireland | 4 | $99 |
Investigators on these documents
FEI number 3012889718 · most recent document Jan 24, 2023
About Alexion Pharma International Operations Limited
How many FDA Form 483s has Alexion Pharma International Operations Limited received?
FDA Intel has 1 Form 483 on file for Alexion Pharma International Operations Limited; the most recent is dated Jan 24, 2023.
When was Alexion Pharma International Operations Limited last inspected by FDA?
The most recent FDA inspection document on file for Alexion Pharma International Operations Limited is a Form 483 dated Jan 24, 2023, for the site in Dublin, Ireland.
What did FDA cite at Alexion Pharma International Operations Limited?
The regulations cited most in the observations on file for Alexion Pharma International Operations Limited are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.42 (Design and construction features), 1 time.