Panacea Biotec Pharma Limited

FDA Regulatory Profile

Panacea Biotec Pharma Limited has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Oct 12, 2023 · OAI

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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 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 12, 2023Malpur, IndiaDrugsOfficial Action Indicated (OAI)3007187282
Jun 8, 2022Malpur, IndiaDrugsOfficial Action Indicated (OAI)3007187282
Feb 20, 2020Malpur, IndiaDrugsOfficial Action Indicated (OAI)3007187282
Apr 30, 2019Malpur, IndiaDrugsNo Action Indicated (NAI)3007187282
Dec 13, 2017Malpur, IndiaDrugsVoluntary Action Indicated (VAI)3007187282
Dec 11, 2015Malpur, IndiaDrugsVoluntary Action Indicated (VAI)3007187282
Oct 25, 2013Malpur, IndiaDrugsVoluntary Action Indicated (VAI)3007187282
Sep 7, 2012Malpur, IndiaDrugsNo Action Indicated (NAI)3007187282
Nov 13, 2009Malpur, IndiaDrugsNo Action Indicated (NAI)3007187282

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 3007187282Malpur, India9Oct 12, 2023

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