FDA Inspection
Takeda Ireland LtdTakeda Ireland Ltd – FDA Inspection, Apr 27, 2018
Record Details
This FDA Inspection record concerns Takeda Ireland Ltd, with an inspection on April 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 463ddebf-b0f1-4c86-b021-d0762b881b97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049773
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of Takeda Ireland Ltd
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 28, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 2, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 20, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 30, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Takeda Ireland Ltd
- FDA Inspection 1255720 - 2022-12-09
- FDA Inspection 1128233 - 2020-02-28
- FDA Inspection 963936 - 2016-03-02
- FDA Inspection 812536 - 2012-12-20
- FDA Inspection 585923 - 2009-04-30
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