Hetero Labs Ltd. - Unit IX

FDA Regulatory Profile

Hetero Labs Ltd. - Unit IX has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 8, 2022 · 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
Inspections5Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 8, 2022Visakhapatnam, IndiaDrugsVoluntary Action Indicated (VAI)3009093782
May 14, 2019Visakhapatnam, IndiaDrugsOfficial Action Indicated (OAI)3009093782
Aug 18, 2017Visakhapatnam, IndiaDrugsVoluntary Action Indicated (VAI)3009093782
Sep 29, 2014Visakhapatnam, IndiaDrugsVoluntary Action Indicated (VAI)3009093782
Dec 15, 2011Visakhapatnam, IndiaDrugsNo Action Indicated (NAI)3009093782

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 3009093782Visakhapatnam, India5Nov 8, 2022

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