Recordati Industria Chimica E Farmaceutica S.P.A. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Recordati Industria Chimica E Farmaceutica S.P.A. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Recordati Industria Chimica E Farmaceutica S.P.A." is on file.

What these totals cover: FDA records filed under the name "Recordati Industria Chimica E Farmaceutica S.P.A." and its spelling variant "Recordati Industria Chimica E Farmaceutica".

Latest inspection
Oct 3, 2025 · VAI

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
Inspections7Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Recordati Industria Chimica E Farmaceutica S.P.A.: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202210000
202100000
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.

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Recent FDA inspections

7 inspections from Jul 23, 2010 to Oct 3, 2025.

DateSiteProductClassificationFEI
Oct 3, 2025Aprilia, ItalyDrugsVoluntary Action Indicated (VAI)3002807989
Sep 30, 2022Aprilia, ItalyDrugsVoluntary Action Indicated (VAI)3002807989
Jun 22, 2019Aprilia, ItalyDrugsVoluntary Action Indicated (VAI)3002807989
Jun 7, 2018Aprilia, ItalyDrugsNo Action Indicated (NAI)3002807989
Jul 1, 2016Aprilia, ItalyDrugsVoluntary Action Indicated (VAI)3002807989
Dec 20, 2013Aprilia, ItalyVeterinaryNo Action Indicated (NAI)3002807989
Jul 23, 2010Aprilia, ItalyDrugsVoluntary Action Indicated (VAI)3002807989
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

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002807989Aprilia, Italy7Oct 3, 2025

Recordati Industria Chimica E Farmaceutica S.P.A. and the FDA: common questions

Has Recordati Industria Chimica E Farmaceutica S.P.A. received an FDA warning letter?

No FDA warning letter addressed to the name "Recordati Industria Chimica E Farmaceutica S.P.A." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Recordati Industria Chimica E Farmaceutica S.P.A. received an FDA Form 483?

FDA has not published a Form 483 for "Recordati Industria Chimica E Farmaceutica S.P.A." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Recordati Industria Chimica E Farmaceutica S.P.A.?

The most recent FDA inspection on file ended Oct 3, 2025 at Aprilia, Italy and was classified VAI. FDA has 7 inspections of Recordati Industria Chimica E Farmaceutica S.P.A. on file.

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