Patheon Italia S.P.A

FDA Regulatory Profile

Patheon Italia S.P.A has 0 FDA recalls, 24 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 10, 2026 · VAI

Newer recall under related name Life Technologies Holdings: Aug 14, 2026, Z-0211-2027.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections24Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Life Technologies Holdings
Same company group
5050Aug 14, 2026 (Z-0211-2027)
Life Technologies Corporation
Same company group
138160Feb 7, 2024 (Z-1426-2024)
Thermo Fisher Scientific
Same company group
16530Feb 1, 2021 (Z-1202-2021)
Life Technologies
Same company group
10420Aug 24, 2018 (Z-0174-2019)
Affymetrix
Same company group
1460Apr 14, 2016 (Z-1909-2016)
Fisher Scientific
Same company group
2010Feb 5, 2014 (Z-1521-2014)
Patheon Manufacturing Services
Same company group
00270—
Patheon Softgels
Same company group
00170—
Patheon Pharmaceuticals
Same company group
00160—
Patheon
Same company group
00150—
Patheon Biologics
Same company group
00120—
Patheon Puerto Rico
Same company group
00120—

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 10, 2026Monza, ItalyBiologicsVoluntary Action Indicated (VAI)3003065803
Jan 30, 2026Ferentino, ItalyBiologicsNo Action Indicated (NAI)3004110157
Sep 29, 2023Monza, ItalyBiologicsVoluntary Action Indicated (VAI)3003065803
May 26, 2023Monza, ItalyDrugsVoluntary Action Indicated (VAI)3003065803
Jan 26, 2023Monza, ItalyDrugsVoluntary Action Indicated (VAI)3003065803
Jun 14, 2022Ferentino, ItalyBiologicsNo Action Indicated (NAI)3004110157
Apr 8, 2022Monza, ItalyDrugsVoluntary Action Indicated (VAI)3003065803
Feb 25, 2022Ferentino, ItalyDrugsVoluntary Action Indicated (VAI)3004110157
Jul 5, 2019Monza, ItalyDrugsVoluntary Action Indicated (VAI)3003065803
Sep 21, 2018Ferentino, ItalyDrugsVoluntary Action Indicated (VAI)3004110157
Feb 6, 2018Monza, ItalyDrugsNo Action Indicated (NAI)3003065803
Oct 31, 2016Ferentino, ItalyBiologicsNo Action Indicated (NAI)3004110157
May 20, 2016Monza, ItalyDrugsVoluntary Action Indicated (VAI)3003065803
Dec 16, 2015Ferentino, ItalyDrugsVoluntary Action Indicated (VAI)3004110157
May 19, 2015Ferentino, ItalyDrugsOfficial Action Indicated (OAI)3004110157
Apr 8, 2014Monza, ItalyDrugsVoluntary Action Indicated (VAI)3003065803
Oct 31, 2013Ferentino, ItalyBiologicsVoluntary Action Indicated (VAI)3004110157
Jun 21, 2013Ferentino, ItalyDrugsVoluntary Action Indicated (VAI)3004110157
Jun 11, 2013Monza, ItalyDrugsVoluntary Action Indicated (VAI)3003065803
Nov 11, 2011Ferentino, ItalyDrugsVoluntary Action Indicated (VAI)3004110157

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3003065803Monza, Italy12Feb 10, 2026
FEI 3004110157Ferentino, Italy12Jan 30, 2026

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