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Laboratorios Biogalenic S.A. DE C.V.

FDA Regulatory Profile

Laboratorios Biogalenic S.A. DE C.V. appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on January 14, 2026.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPJanuary 14, 2026
K243001Sterile Water USP and Sterile 0.9% Normal Saline USPMarch 6, 2025
K242717Laboratorios Biogalenic Sterile Water for Inhalation, USPJanuary 30, 2025

FDA data resources