FDA Inspection
Takeda Manufacturing Austria AGTakeda Manufacturing Austria AG – FDA Inspection, Sep 15, 2026
Record Details
This FDA Inspection record concerns Takeda Manufacturing Austria AG, with an inspection on September 15, 2026, issued by the Office of Inspections and Investigations, covering biologics.
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ID · 0c2be70e-8880-4b5d-85cd-adebc9683519
Inspection Facts
- Inspection number
- 1335724
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 600.14(a)(1)Who must report - manufacturer
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Other FDA inspections of Takeda Manufacturing Austria AG
8| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2026 | Not classified | Office of Inspections and Investigations | |
| June 24, 2022 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 2, 2018 | Not classified | Office of Inspections and Investigations | |
| February 5, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 31, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Takeda Manufacturing Austria AG
- FDA Inspection 1331016 - 2026-07-17
- FDA Inspection 1175171 - 2022-06-24
- FDA Inspection 1043241 - 2018-02-02
- FDA Inspection 958990 - 2016-02-05
- FDA Inspection 772061 - 2012-01-31
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