Galentic Pharma (India) Private Limited

FDA Regulatory Profile

Galentic Pharma (India) Private Limited has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 12, 2018 · 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
Inspections2Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Galentic Pharma (India) Pvt
Same company group
0040—

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 12, 2018Navi Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3008523281
Mar 3, 2017Navi Mumbai, IndiaDrugsOfficial Action Indicated (OAI)3008523281

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 3008523281Navi Mumbai, India2Feb 12, 2018

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