Alexion Pharma International Operations Limited
Form 483 issued January 24, 2023 · Dublin, Ireland
- Inspection
- Jan 16 – Jan 24, 2023
- Investigators
- Jacek Cieslak· Mamta Kapoor-Bhushan· Zhong Li
- Observations
- 4
- Pages
- 6
- FEI number
- 3012889718
In short: On January 24, 2023, FDA issued a Form 483 with 4 observations to Alexion Pharma International Operations Limited in Dublin, DR (FEI 3012889718) after an inspection that ran Jan 16 – Jan 24, 2023. The investigators were Jacek Cieslak, Mamta Kapoor-Bhushan and Zhong Li. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a lack of assurance that your drug substance (DS) manufacturing operations in the bulk…
- 02
Your firm has not established adequate procedural controls to protect the electronic data acquisition systems used…
- 03
Standard Operating procedures or work instructions are not…
- 04
Your firm’s quality unit’s oversight of your GMP…
This inspection in context
Jacek Cieslak
6 documents · 2019–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Japan.
The firmAlexion Pharma International Operations Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alexion Pharma International Operations Limited?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Alexion Pharma International Operations Limited?
Jacek Cieslak, Mamta Kapoor-Bhushan and Zhong Li are named on this Form 483, for the inspection of Jan 16 – Jan 24, 2023. Each investigator has a profile showing what they cite most.
When was Alexion Pharma International Operations Limited inspected by FDA?
The inspection ran Jan 16 – Jan 24, 2023, and the Form 483 is dated January 24, 2023.
How do I get the full Form 483 for Alexion Pharma International Operations Limited?
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.