Laboratorios Leon Farma SAU

FDA Regulatory Profile

Laboratorios Leon Farma SAU has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 11, 2025 · 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
Inspections8Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 11, 2025Villaquilambre, SpainDrugsVoluntary Action Indicated (VAI)3006188375
Jan 17, 2024Villaquilambre, SpainDrugsVoluntary Action Indicated (VAI)3006188375
Mar 31, 2023Villaquilambre, SpainDrugsNo Action Indicated (NAI)3006188375
Feb 25, 2021Villaquilambre, SpainDrugsNo Action Indicated (NAI)3006188375
Mar 8, 2018Villaquilambre, SpainDrugsNo Action Indicated (NAI)3006188375
Mar 28, 2014Villaquilambre, SpainDrugsNo Action Indicated (NAI)3006188375
Feb 9, 2012Villaquilambre, SpainDrugsVoluntary Action Indicated (VAI)3006188375
Feb 26, 2009Villaquilambre, SpainDrugsVoluntary Action Indicated (VAI)3006188375

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 3006188375Villaquilambre, Spain8Jul 11, 2025

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