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Sanofi Winthrop Industrie FDA Inspection Record

FEI 3002972083 · Inspections, Form 483s, warning letters and import refusals

Sanofi Winthrop Industrie is an FDA-registered facility (FEI 3002972083) located in Marcy L Etoile, FR. Registered operations: MANUFACTURE. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Sep 29, 2023: Voluntary Action Indicated (VAI)
Inspections on record
4 (4 VAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Jul 12, 2012
Form 483 and inspection documents
1 in FDA's reading room
Recalls as the recalling firm
1, latest Apr 26, 2016
Import refusals
2

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 25, 2015Voluntary Action Indicated (VAI)No citations listed
Jun 21, 2013Voluntary Action Indicated (VAI)No citations listed
Apr 2, 2010Voluntary Action Indicated (VAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Apr 26, 2016Class IIIB-0120-2017Rabies Immune Globulin (Human)
Sanofi Pasteur's IMOGAM RABIES-HT (Rabies Immune Globulin [Human] USP, Heat Treated), with an antibody content that has declined below the…

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Sep 29, 2023, which is not always the inspection or issue date. Published by FDA Oct 26, 2026.

FDA record score

4 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

5 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAISep 29, 20236 x 0.63.6
Inspection classified VAISep 25, 201510 years or older, so it adds no points0
Inspection classified VAIJun 21, 201310 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsJul 12, 201210 years or older, so it adds no points0
Inspection classified VAIApr 2, 201010 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Sanofi Winthrop Industrie
Location
Marcy L Etoile (FR)
Registration Expires
Dec 31, 2026
Operations
MANUFACTURE
Source
decrs

Compliance actions

Import refusals

FDA data resources

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