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Gateway Analytical, LLC

FDA Regulatory Profile

Gateway Analytical, LLC has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 20, 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
Inspections4Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 20, 2026Gibsonia, PADrugsVoluntary Action Indicated (VAI)3009255642
Sep 16, 2022Gibsonia, PADrugsNo Action Indicated (NAI)3009255642
Jan 15, 2015Gibsonia, PADrugsNo Action Indicated (NAI)3009255642
Nov 5, 2012Gibsonia, PADrugsNo Action Indicated (NAI)3009255642

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 3009255642Gibsonia, PA4Mar 20, 2026

FDA data resources

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