FDA Inspection
Sanofi Vaccines US Inc.Sanofi Vaccines US Inc. – FDA Inspection, Aug 20, 2026
Record Details
This FDA Inspection record concerns Sanofi Vaccines US Inc., with an inspection on August 20, 2026, issued by the Philadelphia District Office, covering biologics.
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ID · 403f013c-8df6-4e0c-8ee6-74afdb31d4aa
Inspection Facts
- Inspection number
- 1328608
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Sanofi Vaccines US Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2025 | Not classified | Philadelphia District Office | |
| August 2, 2024 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| April 22, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 26, 2018 | Not classified | Philadelphia District Office | |
| June 15, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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