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Aragen Life Sciences Limited

FDA Regulatory Profile

Aragen Life Sciences Limited has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 14, 2025 · NAI

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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
Inspections5Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 14, 2025Hyderabad, IndiaDrugsNo Action Indicated (NAI)3011573185
Mar 21, 2025Hyderabad, IndiaDrugsVoluntary Action Indicated (VAI)3005851210
May 3, 2019Hyderabad, IndiaDrugsNo Action Indicated (NAI)3011573185
May 4, 2018Hyderabad, IndiaDrugsVoluntary Action Indicated (VAI)3005851210
Aug 13, 2015Hyderabad, IndiaDrugsVoluntary Action Indicated (VAI)3005851210

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 3011573185Hyderabad, India2May 14, 2025
FEI 3005851210Hyderabad, India3Mar 21, 2025

FDA data resources

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