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Ecron Acunova Limited

FDA Regulatory Profile

Ecron Acunova Limited has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 29, 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
Inspections9Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 29, 2025Bangalore, Karnataka, IndiaDrugsNo Action Indicated (NAI)3038282216
Nov 10, 2022Chennai, IndiaDrugsNo Action Indicated (NAI)3014326883
Jul 1, 2022Udupi, IndiaDrugsNo Action Indicated (NAI)3006355435
May 17, 2019Chennai, IndiaDrugsNo Action Indicated (NAI)3014326883
Dec 13, 2018Mangalore, IndiaDrugsVoluntary Action Indicated (VAI)3006720730
Nov 30, 2018Udupi, IndiaDrugsVoluntary Action Indicated (VAI)3006355435
Jul 27, 2018Bangalore, Karnataka, IndiaDrugsNo Action Indicated (NAI)3038282216
Jul 27, 2018Udupi, IndiaDrugsNo Action Indicated (NAI)3006355435
May 24, 2013Frankfurt Am Main, GermanyDrugsNo Action Indicated (NAI)3010192327

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 3038282216Bangalore, Karnataka, India2Aug 29, 2025
FEI 3014326883Chennai, India2Nov 10, 2022
FEI 3006355435Udupi, India3Jul 1, 2022
FEI 3006720730Mangalore, India1Dec 13, 2018
FEI 3010192327Frankfurt Am Main, Germany1May 24, 2013

FDA data resources

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