Patheon France S.A.S FDA Inspection Record

FEI 3004468553 · Inspections, Form 483s, warning letters and import refusals

Patheon France S.A.S is an FDA-registered facility (FEI 3004468553) located in FR. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 29, 2023: Voluntary Action Indicated (VAI)
Inspections on record
5 (5 VAI)
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
9

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
Sep 29, 2023Voluntary Action Indicated (VAI)No citations listed
Sep 27, 2019Voluntary Action Indicated (VAI)No citations listed
Jun 8, 2018Voluntary Action Indicated (VAI)Procedures for non-sterile drug products (21 CFR 211.113(a))
Mar 11, 2016Voluntary Action Indicated (VAI)No citations listed
Mar 28, 2014Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Patheon France S.A.S.
Location
FR
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

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