Takeda Austria GmbH

FDA Regulatory Profile

Takeda Austria GmbH has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 11, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections6Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 11, 2025Linz, AustriaBiologicsNo Action Indicated (NAI)3001157285
Feb 14, 2025Linz, AustriaDrugsVoluntary Action Indicated (VAI)3001157285
Nov 9, 2018Linz, AustriaBiologicsVoluntary Action Indicated (VAI)3001157285
Jan 23, 2017Linz, AustriaBiologicsVoluntary Action Indicated (VAI)3001157285
May 28, 2015Linz, AustriaBiologicsVoluntary Action Indicated (VAI)3001157285
Feb 11, 2010Linz, AustriaDrugsVoluntary Action Indicated (VAI)3001157285

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

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3001157285Linz, Austria6Sep 11, 2025

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.