Galephar Pharmaceutical Research Inc.

FDA Regulatory Profile

Galephar Pharmaceutical Research Inc. has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 5, 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
Inspections11Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 5, 2025Humacao, PRDrugsNo Action Indicated (NAI)3008206797
Oct 18, 2024Juncos, PRDrugsVoluntary Action Indicated (VAI)3003068480
Nov 1, 2019Humacao, PRDrugsVoluntary Action Indicated (VAI)3008206797
Nov 23, 2015Juncos, PRDrugsVoluntary Action Indicated (VAI)3003068480
Jun 11, 2015Humacao, PRDrugsVoluntary Action Indicated (VAI)3008206797
Jan 15, 2013Humacao, PRDrugsNo Action Indicated (NAI)3008206797
May 7, 2012Humacao, PRDrugsVoluntary Action Indicated (VAI)3008206797
Sep 29, 2011Juncos, PRDrugsVoluntary Action Indicated (VAI)3003068480
Jun 4, 2010Juncos, PRDrugsNo Action Indicated (NAI)3003068480
Jan 30, 2009Juncos, PRDrugsVoluntary Action Indicated (VAI)3003068480
Nov 12, 2008Juncos, PRDrugsNo Action Indicated (NAI)3003068480

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 3008206797Humacao, PR5Jun 5, 2025
FEI 3003068480Juncos, PR6Oct 18, 2024

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