Olon S.P.A. FDA Record

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

Olon S.P.A. has 0 FDA recalls, 47 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Olon S.P.A." is on file.

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

Latest inspection
Jan 16, 2026 · 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
Inspections47Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Olon S.P.A.: FDA inspections per year 2017: 2 inspections220172018: 5 inspections520182019: 6 inspections620192020: 1 inspections120202021: 1 inspections120212022: 0 inspections020222023: 5 inspections520232024: 1 inspections120242025: 2 inspections220252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202520000
202410000
202350000
202200000
202110000
202010000
201960000
201850000
201720000

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

47 inspections from Mar 27, 2009 to Jan 16, 2026. Showing the 20 most recent. View all 47 inspections

DateSiteProductClassificationFEI
Jan 16, 2026Casaletto Lodigiano, ItalyDrugsVoluntary Action Indicated (VAI)3002808159
Apr 11, 2025Settimo Torinese, ItalyDrugsVoluntary Action Indicated (VAI)3002806373
Mar 28, 2025Rodano, ItalyDrugsVoluntary Action Indicated (VAI)3002716636
May 24, 2024Capua, ItalyDrugsVoluntary Action Indicated (VAI)3002807048
Jul 13, 2023Garbagnate Milanese, ItalyDrugsVoluntary Action Indicated (VAI)3002807440
Mar 3, 2023Segrate, ItalyDrugsVoluntary Action Indicated (VAI)3002807457
Feb 16, 2023Mulazzano, ItalyDrugsVoluntary Action Indicated (VAI)3002808211
Feb 10, 2023Garessio, ItalyDrugsVoluntary Action Indicated (VAI)3003677897
Feb 9, 2023Dorno, ItalyDrugsVoluntary Action Indicated (VAI)3009407861
Oct 1, 2021Settimo Torinese, ItalyDrugsVoluntary Action Indicated (VAI)3002806373
Jan 24, 2020Mulazzano, ItalyDrugsVoluntary Action Indicated (VAI)3002808211
Oct 17, 2019Garessio, ItalyDrugsVoluntary Action Indicated (VAI)3003677897
Aug 9, 2019Garbagnate Milanese, ItalyDrugsVoluntary Action Indicated (VAI)3002807440
Aug 2, 2019Casaletto Lodigiano, ItalyDrugsNo Action Indicated (NAI)3002808159
Jul 25, 2019Dorno, ItalyDrugsVoluntary Action Indicated (VAI)3009407861
May 24, 2019Rodano, ItalyDrugsVoluntary Action Indicated (VAI)3002716636
Apr 11, 2019Capua, ItalyDrugsVoluntary Action Indicated (VAI)3002807048
Sep 14, 2018Settimo Torinese, ItalyDrugsVoluntary Action Indicated (VAI)3002806373
May 23, 2018Dorno, ItalyDrugsVoluntary Action Indicated (VAI)3009407861
May 18, 2018Mulazzano, ItalyDrugsVoluntary Action Indicated (VAI)3002808211
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

9 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002808159Casaletto Lodigiano, Italy5Jan 16, 2026
FEI 3002806373Settimo Torinese, Italy5Apr 11, 2025
FEI 3002716636Rodano, Italy6Mar 28, 2025
FEI 3002807048Capua, Italy5May 24, 2024
FEI 3002807440Garbagnate Milanese, Italy4Jul 13, 2023
FEI 3002807457Segrate, Italy5Mar 3, 2023
FEI 3002808211Mulazzano, Italy7Feb 16, 2023
FEI 3003677897Garessio, Italy5Feb 10, 2023
FEI 3009407861Dorno, Italy5Feb 9, 2023

Olon S.P.A. and the FDA: common questions

Has Olon S.P.A. received an FDA warning letter?

No FDA warning letter addressed to the name "Olon 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 Olon S.P.A. received an FDA Form 483?

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

When did the FDA last inspect Olon S.P.A.?

The most recent FDA inspection on file ended Jan 16, 2026 at Casaletto Lodigiano, Italy and was classified VAI. FDA has 47 inspections of Olon S.P.A. on file.

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