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FDA Inspection
•Sanofi Vaccines US Inc.•August 2, 2024

Sanofi Vaccines US Inc. – FDA Inspection, Aug 2, 2024

Record Details

This FDA Inspection record concerns Sanofi Vaccines US Inc., with an inspection on August 2, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Sanofi Vaccines US Inc.
Inspection Date
August 2, 2024
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Scott T. Ballard (FDA Associated Person)
View Company Profile

ID · fd3e0cc3-0299-4ace-88ed-f585e3cab818

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1229985
FDA center
Biologics
Project area
Vaccines and Allergenic Products

FDA Citations

1
  1. 21 CFR 211.68(b)input/output verification

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Sanofi Vaccines US Inc.

11
DateClassificationOfficeProject area
August 20, 2026Not classifiedPhiladelphia District OfficeDrug Quality Assurance
November 6, 2025Not classifiedPhiladelphia District Office
April 22, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 26, 2018Not classifiedPhiladelphia District Office
June 15, 2018NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 11 other inspections on the company page
Other documents for Sanofi Vaccines US Inc.
  • FDA Inspection 1328608 - 2026-08-20
  • FDA Inspection 1298398 - 2025-11-06
  • FDA Inspection 1205715 - 2023-04-22
  • FDA Inspection 1076207 - 2018-10-26
  • FDA Inspection 1056859 - 2018-06-15

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