Patheon Inc.

FDA Regulatory Profile

Patheon Inc. has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 24, 2023 · VAI

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

Part of the Thermo Fisher corporate family.

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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
Inspections15Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Thermo Fisher
parent company
1000May 4, 2018 (Z-2137-2018)
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 Italia
Same company group
00240—
Patheon Softgels
Same company group
00170—
Patheon Pharmaceuticals
Same company group
00160—
Patheon Biologics
Same company group
00120—

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 24, 2023Mississauga, CanadaDrugsVoluntary Action Indicated (VAI)3000264888
Feb 17, 2023Whitby, CanadaDrugsVoluntary Action Indicated (VAI)3003516812
Apr 12, 2019Mississauga, CanadaDrugsVoluntary Action Indicated (VAI)3000264888
Sep 14, 2018Whitby, CanadaDrugsVoluntary Action Indicated (VAI)3003516812
Dec 9, 2016Whitby, CanadaDrugsNo Action Indicated (NAI)3003516812
Dec 2, 2016Mississauga, CanadaDrugsNo Action Indicated (NAI)3000264888
Feb 26, 2016Whitby, CanadaDrugsVoluntary Action Indicated (VAI)3003516812
Nov 13, 2015Mississauga, CanadaDrugsVoluntary Action Indicated (VAI)3000264888
Jan 30, 2015Mississauga, CanadaDrugsVoluntary Action Indicated (VAI)3000264888
Apr 4, 2014Whitby, CanadaDrugsNo Action Indicated (NAI)3003516812
May 24, 2013Whitby, CanadaDrugsVoluntary Action Indicated (VAI)3003516812
Apr 26, 2013Mississauga, CanadaDrugsVoluntary Action Indicated (VAI)3000264888
Jul 7, 2011Whitby, CanadaDrugsNo Action Indicated (NAI)3003516812
Feb 18, 2011Mississauga, CanadaDrugsVoluntary Action Indicated (VAI)3000264888
Jan 27, 2009Whitby, CanadaDrugsVoluntary Action Indicated (VAI)3003516812

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 3000264888Mississauga, Canada7Feb 24, 2023
FEI 3003516812Whitby, Canada8Feb 17, 2023

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