Patheon Manufacturing Services LLC

FDA Regulatory Profile

Patheon Manufacturing Services LLC has 0 FDA recalls, 27 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 30, 2026 · NAI

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
Inspections27Nov 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 Italia
Same company group
00240—
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
Jun 30, 2026Greenville, NCBiologicsNo Action Indicated (NAI)1018495
Sep 26, 2025Greenville, NCVeterinaryNo Action Indicated (NAI)1018495
Jun 13, 2024Ridgefield, NJBiologicsVoluntary Action Indicated (VAI)2246315
Mar 18, 2024Ridgefield, NJDrugsVoluntary Action Indicated (VAI)2246315
Feb 23, 2024Greenville, NCBiologicsVoluntary Action Indicated (VAI)1018495
Aug 4, 2022Greenville, NCBiologicsVoluntary Action Indicated (VAI)1018495
May 17, 2019Greenville, NCVeterinaryNo Action Indicated (NAI)1018495
Dec 17, 2018Ridgefield, NJDevicesVoluntary Action Indicated (VAI)2246315
Jul 17, 2018Greenville, NCBiologicsVoluntary Action Indicated (VAI)1018495
Mar 28, 2018Greenville, NCDevicesNo Action Indicated (NAI)1018495
Dec 7, 2017Ridgefield, NJDrugsVoluntary Action Indicated (VAI)2246315
Apr 20, 2017Greenville, NCDrugsNo Action Indicated (NAI)1018495
Dec 17, 2015Greenville, NCVeterinaryVoluntary Action Indicated (VAI)1018495
Aug 26, 2015Ridgefield, NJDrugsNo Action Indicated (NAI)2246315
Sep 12, 2014Greenville, NCDrugsVoluntary Action Indicated (VAI)1018495
Apr 11, 2014Greenville, NCDrugsVoluntary Action Indicated (VAI)1018495
Jan 21, 2014Ridgefield, NJDrugsVoluntary Action Indicated (VAI)2246315
Jan 25, 2013Greenville, NCDrugsNo Action Indicated (NAI)1018495
Sep 12, 2012Ridgefield, NJDevicesNo Action Indicated (NAI)2246315
Apr 20, 2012Greenville, NCDrugsVoluntary Action Indicated (VAI)1018495

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 1018495Greenville, NC16Jun 30, 2026
FEI 2246315Ridgefield, NJ11Jun 13, 2024

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