Patheon Puerto Rico, Inc.

FDA Regulatory Profile

Patheon Puerto Rico, Inc. has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 12, 2022 · 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
Inspections12Nov 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 Pharmaceuticals
Same company group
00160—
Patheon
Same company group
00150—
Patheon Biologics
Same company group
00120—

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 12, 2022Manati, PRDrugsVoluntary Action Indicated (VAI)3003113148
Oct 15, 2019Manati, PRDrugsVoluntary Action Indicated (VAI)3003113148
May 31, 2018Manati, PRDrugsVoluntary Action Indicated (VAI)3003113148
Jun 21, 2016Manati, PRDrugsVoluntary Action Indicated (VAI)3003113148
Sep 3, 2015Manati, PRDrugsVoluntary Action Indicated (VAI)3003113148
Aug 11, 2014Manati, PRDrugsVoluntary Action Indicated (VAI)3003113148
Jun 12, 2013Manati, PRDrugsVoluntary Action Indicated (VAI)3003113148
Mar 28, 2013Caguas, PRDrugsVoluntary Action Indicated (VAI)2650178
Jun 15, 2011Manati, PRDrugsVoluntary Action Indicated (VAI)3003113148
May 4, 2010Caguas, PRDrugsVoluntary Action Indicated (VAI)2650178
Apr 8, 2009Caguas, PRDrugsVoluntary Action Indicated (VAI)2650178
Feb 4, 2009Manati, PRDrugsVoluntary Action Indicated (VAI)3003113148

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 3003113148Manati, PR9Jul 12, 2022
FEI 2650178Caguas, PR3Mar 28, 2013

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