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Alfasigma S.P.A.

FDA Regulatory Profile

Alfasigma S.P.A. has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Alfasigma S.P.A." and its spelling variant "Alfasigma".

Latest inspection
Jan 26, 2024 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections8Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Alfasigma S.P.A.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Alfasigma S.P.A.: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 1 inspections120192020: 0 inspections020202021: 1 inspections120212022: 1 inspections120222023: 0 inspections020232024: 1 inspections120242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
202300000
202210000
202110000
202000000
201910000
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

8 inspections from Sep 16, 2011 to Jan 26, 2024.

DateSiteProductClassificationFEI
Jan 26, 2024Pomezia, ItalyDrugsVoluntary Action Indicated (VAI)3002808171
Sep 27, 2022Alanno, ItalyDrugsVoluntary Action Indicated (VAI)3003911081
May 28, 2021Pomezia, ItalyDrugsVoluntary Action Indicated (VAI)3002808171
Jan 18, 2019Alanno, ItalyDrugsVoluntary Action Indicated (VAI)3003911081
Jun 21, 2018Pomezia, ItalyDrugsVoluntary Action Indicated (VAI)3002808171
Nov 10, 2015Pomezia, ItalyDrugsVoluntary Action Indicated (VAI)3002808171
Jul 3, 2015Alanno, ItalyDrugsVoluntary Action Indicated (VAI)3003911081
Sep 16, 2011Pomezia, ItalyDrugsVoluntary Action Indicated (VAI)3002808171
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002808171Pomezia, Italy5Jan 26, 2024
FEI 3003911081Alanno, Italy3Sep 27, 2022

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FDA data resources

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