Takeda Ireland Limited — FDA Facility Profile
Takeda Ireland Limited is an FDA-registered facility (FEI 3002870748) located in Kilruddery, IE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Dec 9, 2022: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (4 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 9, 2022 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 28, 2020 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 27, 2018 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Calibration/Inspection/Checking not done (21 CFR 211.68(a)) Scientifically sound laboratory controls (21 CFR 211.160(b)) Suitability of testing methods verified (21 CFR 211.194(a)(2)) |
| Mar 2, 2016 | No Action Indicated (NAI) | No citations listed |
| Dec 20, 2012 | No Action Indicated (NAI) | No citations listed |
| Apr 30, 2009 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Takeda Ireland Ltd
- Location
- Kilruddery (IE)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs