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Fresenius Kabi Oncology Limited

FDA Regulatory Profile

Fresenius Kabi Oncology Limited has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 4 compliance actions on record.

Latest inspection
Oct 10, 2023 · OAI

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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
Inspections10Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions4Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 10, 2023Baddi, IndiaDrugsOfficial Action Indicated (OAI)3006210232
May 24, 2017Nadia, IndiaDrugsOfficial Action Indicated (OAI)3003519498
Apr 14, 2017Baddi, IndiaDrugsOfficial Action Indicated (OAI)3006210232
May 22, 2015Baddi, IndiaDrugsOfficial Action Indicated (OAI)3006210232
Mar 3, 2015Nadia, IndiaDrugsOfficial Action Indicated (OAI)3003519498
Jan 18, 2013Nadia, IndiaDrugsOfficial Action Indicated (OAI)3003519498
Aug 28, 2012Baddi, IndiaDrugsVoluntary Action Indicated (VAI)3006210232
Nov 20, 2009Baddi, IndiaDrugsVoluntary Action Indicated (VAI)3006210232
Nov 6, 2009Nadia, IndiaDrugsVoluntary Action Indicated (VAI)3003519498
Nov 20, 2008Baddi, IndiaDrugsVoluntary Action Indicated (VAI)3006210232

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 3006210232Baddi, India6Oct 10, 2023
FEI 3003519498Nadia, India4May 24, 2017

FDA data resources

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