Big Gain

FDA Regulatory Profile

Big Gain has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 22, 2026 · 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
Inspections7Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 22, 2026Plato, MNVeterinaryVoluntary Action Indicated (VAI)2125882
Aug 6, 2025Mankato, MNVeterinaryNo Action Indicated (NAI)2125804
Sep 13, 2023Plato, MNVeterinaryNo Action Indicated (NAI)2125882
Oct 20, 2022Mankato, MNVeterinaryVoluntary Action Indicated (VAI)2125804
Dec 3, 2014Mankato, MNVeterinaryVoluntary Action Indicated (VAI)2125804
Aug 3, 2012Plato, MNVeterinaryNo Action Indicated (NAI)2125882
Mar 4, 2010Plato, MNVeterinaryNo Action Indicated (NAI)2125882

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 2125882Plato, MN4Apr 22, 2026
FEI 2125804Mankato, MN3Aug 6, 2025

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