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Unichem Laboratories Limited

FDA Regulatory Profile

Unichem Laboratories Limited has 0 FDA recalls, 29 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 2, 2026 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections29Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 2, 2026Hupari, IndiaDrugsVoluntary Action Indicated (VAI)3013585679
Jun 20, 2025District Raigad, IndiaDrugsVoluntary Action Indicated (VAI)3004373180
Feb 28, 2025Pithampur, IndiaDrugsVoluntary Action Indicated (VAI)3006456888
Jul 15, 2024Pilerne Bardez, IndiaDrugsVoluntary Action Indicated (VAI)3005497507
Feb 13, 2024Ghaziabad, IndiaDrugsNo Action Indicated (NAI)3004082076
Feb 21, 2020District Raigad, IndiaDrugsNo Action Indicated (NAI)3004373180
Jan 12, 2020Pilerne Bardez, IndiaDrugsVoluntary Action Indicated (VAI)3005497507
Sep 20, 2019Hupari, IndiaDrugsNo Action Indicated (NAI)3013585679
Sep 12, 2019District Raigad, IndiaDrugsNo Action Indicated (NAI)3004373180
Sep 5, 2019Pithampur, IndiaDrugsNo Action Indicated (NAI)3006456888
Aug 23, 2019Ghaziabad, IndiaDrugsVoluntary Action Indicated (VAI)3004082076
Jul 31, 2019Pilerne Bardez, IndiaDrugsVoluntary Action Indicated (VAI)3005497507
Mar 8, 2019Ghaziabad, IndiaDrugsNo Action Indicated (NAI)3004082076
Aug 3, 2018District Raigad, IndiaDrugsVoluntary Action Indicated (VAI)3004373180
Jul 27, 2018Pithampur, IndiaDrugsVoluntary Action Indicated (VAI)3006456888
Jun 29, 2018Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3002808417
Apr 20, 2018Ghaziabad, IndiaDrugsNo Action Indicated (NAI)3004082076
Mar 3, 2017Ghaziabad, IndiaDrugsVoluntary Action Indicated (VAI)3004082076
Jan 29, 2016Pithampur, IndiaDrugsVoluntary Action Indicated (VAI)3006456888
Apr 17, 2015Pilerne Bardez, IndiaDrugsVoluntary Action Indicated (VAI)3005497507

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 3013585679Hupari, India2Feb 2, 2026
FEI 3004373180District Raigad, India7Jun 20, 2025
FEI 3006456888Pithampur, India6Feb 28, 2025
FEI 3005497507Pilerne Bardez, India6Jul 15, 2024
FEI 3004082076Ghaziabad, India7Feb 13, 2024
FEI 3002808417Mumbai, India1Jun 29, 2018

FDA data resources

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