Alexion Pharma International Operations Unlimited Co.
FDA inspection history in Athlone, Ireland, 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 Athlone, Ireland.
Cited most
Across all Alexion Pharma International Operations Unlimited observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Alexion Pharma International Operations Unlimited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Athlone, Ireland
One Form 483 · 2022 · 3 observations
Latest: Form 483, Apr 8, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-04-08 | 483 Form 483 | Athlone, Ireland | 3 | $99 |
Investigators on these documents
FEI number 3011532960 · most recent document Apr 8, 2022
About Alexion Pharma International Operations Unlimited Co.
How many FDA Form 483s has Alexion Pharma International Operations Unlimited Co. received?
FDA Intel has 1 Form 483 on file for Alexion Pharma International Operations Unlimited Co.; the most recent is dated Apr 8, 2022.
When was Alexion Pharma International Operations Unlimited Co. last inspected by FDA?
The most recent FDA inspection document on file for Alexion Pharma International Operations Unlimited Co. is a Form 483 dated Apr 8, 2022, for the site in Athlone, Ireland.
What did FDA cite at Alexion Pharma International Operations Unlimited Co.?
The regulations cited most in the observations on file for Alexion Pharma International Operations Unlimited Co. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.