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Coupler LLC

FDA Regulatory Profile

Coupler LLC has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Mar 2, 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
Inspections6Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 2, 2026West Chester, PADrugsVoluntary Action Indicated (VAI)3003734940
Aug 10, 2023West Chester, PADrugsVoluntary Action Indicated (VAI)3003734940
Aug 12, 2021West Chester, PADrugsOfficial Action Indicated (OAI)3003734940
Mar 10, 2020West Chester, PADrugsOfficial Action Indicated (OAI)3003734940
Apr 27, 2018West Chester, PADrugsOfficial Action Indicated (OAI)3003734940
May 29, 2013West Chester, PADrugsVoluntary Action Indicated (VAI)3003734940

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 3003734940West Chester, PA6Mar 2, 2026

FDA data resources

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