Ipca Laboratories Limited

FDA Regulatory Profile

Ipca Laboratories Limited has 0 FDA recalls, 19 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Dec 5, 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
Inspections19Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 5, 2025Palghar, IndiaDrugsVoluntary Action Indicated (VAI)3006057101
Oct 21, 2023Ratlam, IndiaDrugsVoluntary Action Indicated (VAI)3002807297
Jun 23, 2023Dhar, IndiaDrugsVoluntary Action Indicated (VAI)3007574780
Jun 13, 2023Ratlam, IndiaDrugsVoluntary Action Indicated (VAI)3002807297
Apr 26, 2023Silvassa, IndiaDrugsVoluntary Action Indicated (VAI)3005977675
Sep 20, 2019Palghar, IndiaDrugsVoluntary Action Indicated (VAI)3006057101
Aug 23, 2019Silvassa, IndiaDrugsOfficial Action Indicated (OAI)3005977675
Aug 31, 2017Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3010070496
Mar 8, 2017Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3005888508
Nov 4, 2016Chhatrapati Sambhajinagar, IndiaDrugsNo Action Indicated (NAI)3009227929
Oct 6, 2016Palghar, IndiaDrugsVoluntary Action Indicated (VAI)3006057101
Dec 19, 2014Silvassa, IndiaDrugsOfficial Action Indicated (OAI)3005977675
Oct 17, 2014Dhar, IndiaDrugsOfficial Action Indicated (OAI)3007574780
Jul 18, 2014Ratlam, IndiaDrugsOfficial Action Indicated (OAI)3002807297
Apr 26, 2013Dhar, IndiaDrugsVoluntary Action Indicated (VAI)3007574780
Jul 31, 2012Silvassa, IndiaDrugsVoluntary Action Indicated (VAI)3005977675
Jan 27, 2012Dhar, IndiaDrugsNo Action Indicated (NAI)3007574780
Sep 19, 2011Ratlam, IndiaDrugsVoluntary Action Indicated (VAI)3002807297
May 28, 2010Silvassa, IndiaDrugsVoluntary Action Indicated (VAI)3005977675

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 3006057101Palghar, India3Dec 5, 2025
FEI 3002807297Ratlam, India4Oct 21, 2023
FEI 3007574780Dhar, India4Jun 23, 2023
FEI 3005977675Silvassa, India5Apr 26, 2023
FEI 3010070496Mumbai, India1Aug 31, 2017
FEI 3005888508Mumbai, India1Mar 8, 2017
FEI 3009227929Chhatrapati Sambhajinagar, India1Nov 4, 2016

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