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Sylvan Bio, Inc.

FDA Regulatory Profile

Sylvan Bio, Inc. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 3, 2025 · 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
Inspections4Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 3, 2025Kittanning, PAFood/CosmeticsNo Action Indicated (NAI)3015497509
Sep 27, 2024Kittanning, PAFood/CosmeticsNo Action Indicated (NAI)3010368131
Jun 30, 2022Kittanning, PAFood/CosmeticsNo Action Indicated (NAI)3015497509
Jul 23, 2014Kittanning, PAFood/CosmeticsNo Action Indicated (NAI)3010368131

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 3015497509Kittanning, PA2Sep 3, 2025
FEI 3010368131Kittanning, PA2Sep 27, 2024

FDA data resources

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