Exeltis USA, Inc.

FDA Regulatory Profile

Exeltis USA, Inc. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Sep 22, 2026 · NAI

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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
Inspections5Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 22, 2026Florham Park, NJFood/CosmeticsNo Action Indicated (NAI)3008163531
Jul 2, 2025Florham Park, NJFood/CosmeticsNo Action Indicated (NAI)3008163531
Nov 15, 2024Florham Park, NJDrugsNo Action Indicated (NAI)3008163531
Jan 14, 2019Florham Park, NJDrugsNo Action Indicated (NAI)3008163531
Jun 6, 2017Florham Park, NJDrugsVoluntary Action Indicated (VAI)3008163531

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 3008163531Florham Park, NJ5Sep 22, 2026

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