Sanofi Winthrop Industrie FDA Inspection Record

FEI 3003282644 · Inspections, Form 483s, warning letters and import refusals

Sanofi Winthrop Industrie is an FDA-registered facility (FEI 3003282644) located in Centre, FR. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 27, 2023: Voluntary Action Indicated (VAI)
Inspections on record
6 (3 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
Jan 27, 2023Voluntary Action Indicated (VAI)No citations listed
Oct 10, 2019Voluntary Action Indicated (VAI)No citations listed
Jun 15, 2018Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Jun 6, 2014No Action Indicated (NAI)No citations listed
Mar 23, 2012No Action Indicated (NAI)No citations listed
Apr 29, 2010No Action Indicated (NAI)No citations listed

Facility details

Company
Sanofi Winthrop Industrie
Location
Centre (FR)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

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