Sanofi Winthrop Industrie

FDA Regulatory Profile

Sanofi Winthrop Industrie has 0 FDA recalls, 57 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Oct 4, 2024 · VAI

Newer recall under related name Chattem: Mar 26, 2025, D-0362-2025.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances0Oct 4, 2026Not statedCurrent
Inspections57Oct 26, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Chattem
Same company group
21271Mar 26, 2025 (D-0362-2025)
Sanofi Genzyme
Same company group
1000Dec 11, 2017 (Z-0607-2018)
Genzyme Corporation
Same company group
66261Oct 12, 2017 (D-0075-2018)
Sanofi
Same company group
02120—
Chattem Chemicals
Same company group
0060—
Sanofi Aventis Singapore Pte
Same company group
0060—
Genzyme Biosurgery
Same company group
0400—
Genzyme Polyclonals
Same company group
0020—
Sanofi Aventis Recherche And Developpement
Same company group
0010—
Sanofi Chimie
Same company group
0010—
Sanofi Us Services
Same company group
0010—

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 4, 2024Vitry-Sur-Seine, FranceDrugsVoluntary Action Indicated (VAI)3002808000
Jan 26, 2024Val De Reuil, FranceBiologicsVoluntary Action Indicated (VAI)3006287395
Jan 12, 2024Neuville-Sur-Saone, FranceBiologicsNo Action Indicated (NAI)3014781447
Nov 22, 2023Carbon Blanc CEDEX, FranceDrugsVoluntary Action Indicated (VAI)3002808208
Nov 17, 2023Lyon, FranceBiologicsVoluntary Action Indicated (VAI)3009194033
Sep 29, 2023Marcy-L'Etoile, FranceBiologicsVoluntary Action Indicated (VAI)3002972083
Sep 15, 2023Sisteron, FranceDrugsVoluntary Action Indicated (VAI)1000476619
May 12, 2023Vitry-Sur-Seine, FranceDrugsVoluntary Action Indicated (VAI)3002808000
Apr 25, 2023Le Trait, FranceDrugsVoluntary Action Indicated (VAI)3003259844
Mar 10, 2023Aramon, FranceDrugsVoluntary Action Indicated (VAI)3002808341
Jan 27, 2023Tours, FranceDrugsVoluntary Action Indicated (VAI)3003282644
Dec 3, 2021Maisons Alfort, FranceDrugsVoluntary Action Indicated (VAI)1000610805
Feb 18, 2020Lyon, FranceBiologicsVoluntary Action Indicated (VAI)3009194033
Feb 7, 2020Le Trait, FranceDrugsVoluntary Action Indicated (VAI)3003259844
Nov 22, 2019Sisteron, FranceDrugsVoluntary Action Indicated (VAI)1000476619
Oct 10, 2019Tours, FranceDrugsVoluntary Action Indicated (VAI)3003282644
Sep 13, 2019Vitry-Sur-Seine, FranceDrugsVoluntary Action Indicated (VAI)3002808000
Mar 29, 2019Aramon, FranceDrugsVoluntary Action Indicated (VAI)3002808341
Jul 17, 2018Aramon, FranceBiologicsVoluntary Action Indicated (VAI)3002808341
Jul 13, 2018Lyon, FranceBiologicsVoluntary Action Indicated (VAI)3009194033

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.