Takeda Austria GmbH
FDA inspection history in Linz, Austria, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Linz, Austria.
Cited most
Across all Takeda Austria observations on file
- 21 CFR 211.198Complaint files1
- 21 CFR 211.65Equipment construction1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
- 21 CFR 600.14Reporting of biological product deviations by licensed manufacturers1
The complete Takeda Austria file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Linz, Austria
One Form 483 · 2018
Latest: Form 483, Nov 9, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-11-09 | 483 Form 483 | Linz, Austria | — | $99 |
Investigators on these documents
FEI number 3001157285 · most recent document Nov 9, 2018
About Takeda Austria GmbH
How many FDA Form 483s has Takeda Austria GmbH received?
FDA Intel has 1 Form 483 on file for Takeda Austria GmbH; the most recent is dated Nov 9, 2018.
When was Takeda Austria GmbH last inspected by FDA?
The most recent FDA inspection document on file for Takeda Austria GmbH is a Form 483 dated Nov 9, 2018, for the site in Linz, Austria.
What did FDA cite at Takeda Austria GmbH?
The regulations cited most in the observations on file for Takeda Austria GmbH are 21 CFR 211.198 (Complaint files), 1 time; 21 CFR 211.65 (Equipment construction), 1 time; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 1 time.