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FDA Inspection
•Sanofi Winthrop Industrie•July 25, 2017

Sanofi Winthrop Industrie – FDA Inspection, Jul 25, 2017

Record Details

This FDA Inspection record concerns Sanofi Winthrop Industrie, with an inspection on July 25, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Sanofi Winthrop Industrie
Inspection Date
July 25, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Jose E. Melendez (FDA Associated Person)
View Company Profile

ID · cad42f47-1aad-4e97-912d-f854d2ceb564

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1022342
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Sanofi Winthrop Industrie

7
DateClassificationOfficeProject area
March 10, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 29, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 17, 2018VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 14, 2016VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
October 25, 2013NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for Sanofi Winthrop Industrie
  • FDA Inspection 1246180 - 2023-03-10
  • FDA Inspection 1118089 - 2019-03-29
  • FDA Inspection 1063584 - 2018-07-17
  • FDA Inspection 998080 - 2016-09-14
  • FDA Inspection 857683 - 2013-10-25

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