Home / Companies / Takeda Manufacturing Austria AG

Takeda Manufacturing Austria AG

FDA Regulatory Profile

Takeda Manufacturing Austria AG has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Takeda Manufacturing Austria AG" and its spelling variant "Takeda Manufacturing Austria".

Latest inspection: Jul 17, 2026 · NAI

Reviewing Takeda Manufacturing Austria AG as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Takeda Manufacturing Austria AG yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	11	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Takeda Manufacturing Austria AG's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	2	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

11 inspections from Jan 21, 2010 to Jul 17, 2026.

Date	Site	Product	Classification	FEI
Jul 17, 2026	Vienna, Austria	Biologics	No Action Indicated (NAI)	3002807133
May 18, 2026	Orth An Der Donau, Austria	Biologics	No Action Indicated (NAI)	3003046565
Apr 24, 2024	Orth An Der Donau, Austria	Drugs	No Action Indicated (NAI)	3003046565
Jun 24, 2022	Vienna, Austria	Biologics	Voluntary Action Indicated (VAI)	3002807133
Mar 1, 2016	Orth An Der Donau, Austria	Biologics	Voluntary Action Indicated (VAI)	3003046565
Feb 5, 2016	Vienna, Austria	Biologics	Voluntary Action Indicated (VAI)	3002807133
Feb 7, 2013	Vienna, Austria	Devices	Voluntary Action Indicated (VAI)	3002807133
Jan 31, 2012	Vienna, Austria	Biologics	Voluntary Action Indicated (VAI)	3002807133
Jan 19, 2012	Vienna, Austria	Biologics	Voluntary Action Indicated (VAI)	3002807133
Jan 28, 2010	Vienna, Austria	Biologics	Voluntary Action Indicated (VAI)	3002807133
Jan 21, 2010	Vienna, Austria	Biologics	Voluntary Action Indicated (VAI)	3002807133

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002807133	Vienna, Austria	8	Jul 17, 2026
FEI 3003046565	Orth An Der Donau, Austria	3	May 18, 2026

Need more than this page shows? Ask about Takeda Manufacturing Austria AG in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.