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Hetero Drugs Limited

FDA Regulatory Profile

Hetero Drugs Limited has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 16, 2025 · 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
Inspections11Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 16, 2025Gummadidala Mandal, Sangareddy, IndiaDrugsVoluntary Action Indicated (VAI)3003510514
Jan 27, 2023Hyderabad, IndiaDrugsNo Action Indicated (NAI)3009307611
Jun 21, 2022Anakapalli, IndiaDrugsVoluntary Action Indicated (VAI)3009225386
Feb 14, 2020Gummadidala Mandal, Sangareddy, IndiaDrugsVoluntary Action Indicated (VAI)3003510514
Mar 2, 2018Gummadidala Mandal, Sangareddy, IndiaDrugsVoluntary Action Indicated (VAI)3003510514
Sep 15, 2017Medak District, IndiaDrugsNo Action Indicated (NAI)3009488373
Feb 10, 2017Anakapalli, IndiaDrugsNo Action Indicated (NAI)3009225386
Feb 25, 2016Gummadidala Mandal, Sangareddy, IndiaDrugsNo Action Indicated (NAI)3003510514
May 2, 2014Gummadidala Mandal, Sangareddy, IndiaDrugsVoluntary Action Indicated (VAI)3003510514
Dec 15, 2011Anakapalli, IndiaDrugsNo Action Indicated (NAI)3009225386
Nov 11, 2010Gummadidala Mandal, Sangareddy, IndiaDrugsNo Action Indicated (NAI)3003510514

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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3003510514Gummadidala Mandal, Sangareddy, India6May 16, 2025
FEI 3009307611Hyderabad, India1Jan 27, 2023
FEI 3009225386Anakapalli, India3Jun 21, 2022
FEI 3009488373Medak District, India1Sep 15, 2017

FDA data resources

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