Patheon Pharmaceuticals Inc.

FDA Regulatory Profile

Patheon Pharmaceuticals Inc. has 0 FDA recalls, 16 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 26, 2025 · 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
Inspections16Nov 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 Italia
Same company group
00240—
Patheon Softgels
Same company group
00170—
Patheon
Same company group
00150—
Patheon Biologics
Same company group
00120—
Patheon Puerto Rico
Same company group
00120—

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 26, 2025Cincinnati, OHDrugsVoluntary Action Indicated (VAI)1510437
Apr 21, 2023Cincinnati, OHDrugsNo Action Indicated (NAI)1510437
Jan 14, 2020Cincinnati, OHDrugsNo Action Indicated (NAI)1510437
Feb 14, 2018Cincinnati, OHDrugsVoluntary Action Indicated (VAI)1510437
Mar 2, 2017Cincinnati, OHDrugsVoluntary Action Indicated (VAI)1510437
Mar 11, 2016Cincinnati, OHDrugsVoluntary Action Indicated (VAI)1510437
Oct 30, 2014Cincinnati, OHDrugsVoluntary Action Indicated (VAI)1510437
Jun 18, 2014Cincinnati, OHDrugsNo Action Indicated (NAI)1510437
Aug 26, 2013Cincinnati, OHDrugsVoluntary Action Indicated (VAI)1510437
May 13, 2013Cincinnati, OHDrugsVoluntary Action Indicated (VAI)1510437
Aug 16, 2012Cincinnati, OHDrugsVoluntary Action Indicated (VAI)1510437
Jan 12, 2012Cincinnati, OHDrugsVoluntary Action Indicated (VAI)1510437
Mar 24, 2011Cincinnati, OHDrugsVoluntary Action Indicated (VAI)1510437
Jan 31, 2011Cincinnati, OHDrugsNo Action Indicated (NAI)1510437
Mar 24, 2010Cincinnati, OHDrugsNo Action Indicated (NAI)1510437
Mar 24, 2010Blue Ash, OHDrugsNo Action Indicated (NAI)3007154864

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 1510437Cincinnati, OH15Sep 26, 2025
FEI 3007154864Blue Ash, OH1Mar 24, 2010

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