Fidia Farmaceutici S.P.A.

FDA Regulatory Profile

Fidia Farmaceutici S.P.A. has 0 FDA recalls, 7 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 9, 2024 · NAI
Latest 510(k)
Jan 9, 2020

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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
Inspections7Oct 27, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 9, 2024Abano Terme, ItalyVeterinaryNo Action Indicated (NAI)3002806986
Jun 27, 2017Abano Terme, ItalyVeterinaryVoluntary Action Indicated (VAI)3002806986
Nov 10, 2016Abano Terme, ItalyDevicesVoluntary Action Indicated (VAI)3002806986
Nov 14, 2014Abano Terme, ItalyDevicesNo Action Indicated (NAI)3002806986
May 23, 2014Abano Terme, ItalyVeterinaryVoluntary Action Indicated (VAI)3002806986
Dec 15, 2010Abano Terme, ItalyDevicesNo Action Indicated (NAI)3002806986
Jul 2, 2009Abano Terme, ItalyDrugsVoluntary Action Indicated (VAI)3002806986

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
K191052HyaloGYN Vaginal Moisturizing SuppositoriesJan 9, 2020
K150883HyaloGYN Vaginal Hydrating GelSep 1, 2015
K094039HYALO GYNMay 7, 2010