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Baxalta US Inc.

FDA Regulatory Profile

Baxalta US Inc. has 0 FDA recalls, 26 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest inspection
Nov 26, 2025 · VAI

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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
Inspections26Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 26, 2025Round Lake, ILBiologicsVoluntary Action Indicated (VAI)3012385969
Nov 7, 2025Los Angeles, CABiologicsNo Action Indicated (NAI)2011021
Jan 30, 2025Social Circle, GABiologicsNo Action Indicated (NAI)3013980449
May 31, 2023Los Angeles, CABiologicsVoluntary Action Indicated (VAI)2011021
Sep 15, 2022Round Lake, ILBiologicsVoluntary Action Indicated (VAI)3012385969
Apr 7, 2022Thousand Oaks, CABiologicsVoluntary Action Indicated (VAI)1000519965
Jul 1, 2021Social Circle, GABiologicsVoluntary Action Indicated (VAI)3013980449
Jan 17, 2020Thousand Oaks, CABiologicsVoluntary Action Indicated (VAI)1000519965
Sep 25, 2019Round Lake, ILBiologicsVoluntary Action Indicated (VAI)3012385969
Nov 2, 2018Los Angeles, CABiologicsVoluntary Action Indicated (VAI)2011021
Jan 19, 2018Thousand Oaks, CABiologicsVoluntary Action Indicated (VAI)1000519965
Dec 13, 2016Los Angeles, CABiologicsVoluntary Action Indicated (VAI)2011021
Mar 10, 2016Thousand Oaks, CABiologicsVoluntary Action Indicated (VAI)1000519965
Sep 9, 2015Westlake Village, CADevicesNo Action Indicated (NAI)3000121413
Mar 13, 2015Los Angeles, CABiologicsVoluntary Action Indicated (VAI)2011021
Feb 28, 2014Thousand Oaks, CABiologicsVoluntary Action Indicated (VAI)1000519965
Sep 20, 2012Los Angeles, CABiologicsVoluntary Action Indicated (VAI)2011021
Mar 29, 2012Westlake Village, CABiologicsNo Action Indicated (NAI)3000121413
Mar 29, 2012Westlake Village, CADevicesNo Action Indicated (NAI)3000121413
Aug 11, 2011Thousand Oaks, CABiologicsVoluntary Action Indicated (VAI)1000519965

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 3012385969Round Lake, IL3Nov 26, 2025
FEI 2011021Los Angeles, CA9Nov 7, 2025
FEI 3013980449Social Circle, GA2Jan 30, 2025
FEI 1000519965Thousand Oaks, CA6Apr 7, 2022
FEI 3000121413Westlake Village, CA5Sep 9, 2015
FEI 3002772556Van Nuys, CA1Apr 16, 2009

FDA data resources

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