Company
IrelandTakeda Ireland Ltd, Kilruddery, Ireland – FDA Inspections
Inspection records and compliance data for Takeda Ireland Ltd in Kilruddery. 6 FDA inspections on record, 1 Form 483, last inspected December 09, 2022.
Company Profile
This profile covers Takeda Ireland Ltd based in Kilruddery, Ireland.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected April 30, 2009. Last inspected December 9, 2022.
Most cited issue areas
- Calibration/Inspection/Checking not done1 inspection
- Procedures not in writing, fully followed1 inspection
- Scientifically sound laboratory controls1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 9, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1255720 |
| February 28, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1128233 |
| April 27, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1049773 |
| March 2, 2016 | NAI | Human Drugs · Drug Quality Assurance | 963936 |
| December 20, 2012 | NAI | Human Drugs · Drug Quality Assurance | 812536 |
| April 30, 2009 | VAI | Human Drugs · Drug Quality Assurance | 585923 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Takeda Ireland Ltd
FEI Number
3002870748
Address
Bray Business Park, Kilruddery, Ireland
Country
Ireland
ID: 9e5263c0-ce04-4edc-b803-33262d4b2d75