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PTC Therapeutics, Inc.

FDA Regulatory Profile

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

Latest inspection
May 22, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 22, 2025Warren, NJDrugsNo Action Indicated (NAI)3003425888
Nov 18, 2024Warren, NJDrugsVoluntary Action Indicated (VAI)3003425888
Aug 12, 2020Warren, NJDrugsNo Action Indicated (NAI)3003425888
Aug 8, 2017Warren, NJDrugsNo Action Indicated (NAI)3003425888

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 3003425888Warren, NJ4May 22, 2025

FDA data resources

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