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PATHEON API, INC.

Manufacturing facility · Florence, SC
Latest FDA inspection
Clean — NAI
Jun 12, 2026 · Drug Quality Assurance
Compliance actions
None on record
No warning letters, injunctions, or seizures.
FDA registration
Active
Expires Dec 31, 2026 · verified Jul 19, 2026
OverviewInspection historyServicesRelated sites

Capabilities

AnalysisAPI ManufactureManufacture

Registered operations per FDA.

FDA inspection history

6 records, Jan 2010 – Jun 2026 · 4 NAI · 2 VAI · 0 OAI

DateClassProject areaCitationsFY
Jun 12, 2026NAIDrug Quality Assurance2026
Jun 28, 2024NAIDrug Quality Assurance2024
Nov 9, 2018VAIDrug Quality Assurance2019
Dec 19, 2014NAIDrug Quality Assurance2015
Jun 8, 2012VAIDrug Quality Assurance2012
Jan 27, 2010NAIDrug Quality Assurance2010

NAI = no action indicated · VAI = voluntary action · OAI = official action.


Compliance actions

None on record — no warning letters, injunctions, or seizures.

Services & instrumentation

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This facility hasn’t claimed its profile to share service lines, instrumentation, GMP scope, or turnaround times. Everything above is verified FDA data; service details are added by the facility after it claims.

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FEI 3000717636 · DUNS 809933534 · Data verified Jul 19, 2026 · How we verify →

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