Alexion Pharma International Operations Unlimited Co.
Form 483 issued April 8, 2022 · Athlone, Ireland
- Inspection
- Mar 31 – Apr 8, 2022
- Investigators
- Richard Ledwidge· Zhang Zhao
- Observations
- 3
- Pages
- 2
- FEI number
- 3011532960
In short: On April 8, 2022, FDA issued a Form 483 with 3 observations to Alexion Pharma International Operations Unlimited Co. in Athlone, Ireland (FEI 3011532960) after an inspection that ran Mar 31 – Apr 8, 2022. The investigators were Richard Ledwidge and Zhang Zhao. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Multiple deviations were issued during production…
- 02
In-process testing in the…
- 03
Cleaning validation of a : ‘esults during cleaning cycle development exceeded acceptance criteria. The firm deemed…
This inspection in context
Richard Ledwidge
18 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmAlexion Pharma International Operations Unlimited Co. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alexion Pharma International Operations Unlimited Co.?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Alexion Pharma International Operations Unlimited Co.?
Richard Ledwidge and Zhang Zhao are named on this Form 483, for the inspection of Mar 31 – Apr 8, 2022. Each investigator has a profile showing what they cite most.
When was Alexion Pharma International Operations Unlimited Co. inspected by FDA?
The inspection ran Mar 31 – Apr 8, 2022, and the Form 483 is dated April 8, 2022.
How do I get the full Form 483 for Alexion Pharma International Operations Unlimited Co.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.