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Zentiva Private Limited

FDA Regulatory Profile

Zentiva Private Limited has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 13, 2025 · NAI

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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 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 13, 2025Ankleshwar, IndiaDrugsNo Action Indicated (NAI)3004086396
Feb 7, 2019Ankleshwar, IndiaDrugsNo Action Indicated (NAI)3004086396
Jul 1, 2016Ankleshwar, IndiaDrugsVoluntary Action Indicated (VAI)3004086396
May 19, 2012Ankleshwar, IndiaDrugsNo Action Indicated (NAI)3004086396
Sep 4, 2009Ankleshwar, IndiaDrugsVoluntary Action Indicated (VAI)3004086396

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 3004086396Ankleshwar, India5Feb 13, 2025

FDA data resources

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