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Hetero Labs Limited

FDA Regulatory Profile

Hetero Labs Limited has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 8, 2023 · 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
Inspections8Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 8, 2023Sangareddy, IndiaDrugsVoluntary Action Indicated (VAI)3004378446
Aug 12, 2021Sangareddy, IndiaDrugsOfficial Action Indicated (OAI)3004378446
Feb 14, 2020Sanath Nagar, IndiaDrugsNo Action Indicated (NAI)3007785633
Sep 28, 2018Sangareddy, IndiaDrugsOfficial Action Indicated (OAI)3004378446
Mar 14, 2017Sangareddy, IndiaDrugsNo Action Indicated (NAI)3004378446
Aug 28, 2014Anakapalli, IndiaDrugsVoluntary Action Indicated (VAI)3011002833
Nov 29, 2013Sangareddy, IndiaDrugsNo Action Indicated (NAI)3004378446
Dec 9, 2011Sangareddy, IndiaDrugsNo Action Indicated (NAI)3004378446

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 3004378446Sangareddy, India6Sep 8, 2023
FEI 3007785633Sanath Nagar, India1Feb 14, 2020
FEI 3011002833Anakapalli, India1Aug 28, 2014

FDA data resources

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