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Bootstrap Runners LLC

FDA Regulatory Profile

Bootstrap Runners LLC has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest inspection
Jul 21, 2022 · OAI

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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
Inspections3Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 21, 2022Raleigh, NCTobaccoOfficial Action Indicated (OAI)3013540774
Sep 2, 2021Raleigh, NCTobaccoOfficial Action Indicated (OAI)3013540774
Jan 29, 2019Raleigh, NCTobaccoNo Action Indicated (NAI)3013540774

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 3013540774Raleigh, NC3Jul 21, 2022

FDA data resources

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