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Dextrum Laboratories

FDA Regulatory Profile

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

Latest inspection
Aug 29, 2024 · 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
Inspections6Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 29, 2024Miami, FLDrugsOfficial Action Indicated (OAI)3003092372
Jul 18, 2023Miami, FLDrugsOfficial Action Indicated (OAI)3003092372
Dec 16, 2022Miami, FLDrugsVoluntary Action Indicated (VAI)3003092372
Nov 17, 2017Miami, FLDrugsVoluntary Action Indicated (VAI)3003092372
Feb 12, 2016Miami, FLDrugsVoluntary Action Indicated (VAI)3003092372
Jul 10, 2012Miami, FLDrugsVoluntary Action Indicated (VAI)3003092372

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 3003092372Miami, FL6Aug 29, 2024

FDA data resources

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