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Medibio USA, LLC

FDA Regulatory Profile

Medibio USA, LLC has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Apr 16, 2019 · VAI
Latest 510(k)
Jun 27, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances1Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 16, 2019Davie, FLDevicesVoluntary Action Indicated (VAI)3014393881

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.

Recent 510(k) Clearances

K-NumberDeviceDate
K180720Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 BevelJun 27, 2018

FDA data resources