Atlas

FDA-Inspected Site

Sanofi Winthrop Industrie

13 FDA inspections are on record for Sanofi Winthrop Industrie in Le Trait, France.

483· Form 483 issued

Le Trait, France · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 11 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-04-25.

At a glance

Inspections

13

Form 483s

11

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Apr 2023 – 25 Apr 2023Human Drugs483On file
3 Feb 2020 – 7 Feb 2020Human DrugsClean
25 Feb 2019 – 1 Mar 2019Human DrugsClean
16 May 2018 – 25 May 2018Human Drugs483On file
6 Feb 2017 – 14 Feb 2017Human Drugs483On file
7 Jul 2016 – 19 Jul 2016Human Drugs483On file
6 Apr 2015 – 14 Apr 2015Human Drugs483On file
7 Apr 2015 – 9 Apr 2015Medical Devices & Rad Health483On file
20 Mar 2014 – 28 Mar 2014Human Drugs483On file
13 Jan 2014 – 20 Jan 2014Biologics483On file
28 Sep 2012Not recorded483On file
15 Feb 2011Not recorded483On file

Investigators

FDA investigators tied to this site in the record.

Debra M Emerson2 insp.
Unnee Ranjan1 insp.
Prabhu P Raju1 insp.
MRA DavisM1 insp.
Wayne E Seifert1 insp.
Omotunde O Osunsanmi1 insp.
Laura Fontan1 insp.
Marion Michaelis1 insp.
Arie Menachem1 insp.
Steven Fong1 insp.
Steven B Hertz1 insp.
Lydia S Chan1 insp.
Jeremy W Rotton1 insp.
Christian Lynch1 insp.
Ramon E Martinez1 insp.
Donald B Ertel1 insp.
Nicole K Trudel1 insp.
Yumi J Hiramine1 insp.

Full site report

Get the verbatim findings behind Sanofi Winthrop Industrie's 11 Form 483s

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat