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Aea Srl

FDA Regulatory Profile

Aea Srl has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 10, 2020 · NAI
Latest 510(k)
Sep 27, 2021

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 10, 2020Maiolati Spontini, ItalyDevicesNo Action Indicated (NAI)3006571738
Jun 15, 2017Maiolati Spontini, ItalyDevicesVoluntary Action Indicated (VAI)3006571738

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
K203674B Dispensing LineSep 27, 2021
K192770S dispensing lineDec 17, 2020
K132011APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SETMar 21, 2014

FDA data resources