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Patheon Inc. FDA Inspection Record

FEI 3003516812 · Inspections, Form 483s, warning letters and import refusals

Patheon Inc. is an FDA-registered facility (FEI 3003516812) located in Whitby, CA. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 8 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Feb 17, 2023: Voluntary Action Indicated (VAI)
Inspections on record
8 (5 VAI, 3 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Feb 17, 2023Voluntary Action Indicated (VAI)Testing and release for distribution (21 CFR 211.165(a))
Sep 14, 2018Voluntary Action Indicated (VAI)Component identity verification (21 CFR 211.84(d)(1))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Written procedures fail to include (21 CFR 211.67(b))
Written record of investigation incomplete (21 CFR 211.192)
Dec 9, 2016No Action Indicated (NAI)No citations listed
Feb 26, 2016Voluntary Action Indicated (VAI)No citations listed
Apr 4, 2014No Action Indicated (NAI)No citations listed
May 24, 2013Voluntary Action Indicated (VAI)No citations listed
Jul 7, 2011No Action Indicated (NAI)No citations listed
Jan 27, 2009Voluntary Action Indicated (VAI)No citations listed

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Patheon Inc.
Location
Whitby (CA)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Import refusals

FDA data resources

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