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Baxter Pharmaceuticals India Pvt Ltd

FDA Regulatory Profile

Baxter Pharmaceuticals India Pvt Ltd has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 3 compliance actions on record.

Latest inspection
Jan 27, 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
Inspections9Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions3Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 27, 2023Ahmedabad, IndiaDrugsOfficial Action Indicated (OAI)3004610460
May 17, 2022Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3004610460
Aug 4, 2017Ahmedabad, IndiaDrugsOfficial Action Indicated (OAI)3004610460
Aug 26, 2016Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3004610460
May 11, 2015Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3004610460
Oct 18, 2013Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3004610460
Mar 2, 2012Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3004610460
Jun 16, 2010Ahmedabad, IndiaDrugsOfficial Action Indicated (OAI)3004610460
Nov 12, 2009Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3004610460

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 3004610460Ahmedabad, India9Jan 27, 2023

FDA data resources

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