FDA Inspection
Sanofi Vaccines US Inc.Sanofi Vaccines US Inc. – FDA Inspection, Apr 22, 2023
Record Details
This FDA Inspection record concerns Sanofi Vaccines US Inc., with an inspection on April 22, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 93795f6a-9e4d-467c-9fd0-a95b0b43b58f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1205715
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Sanofi Vaccines US Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2026 | Not classified | Philadelphia District Office | Drug Quality Assurance |
| November 6, 2025 | Not classified | Philadelphia District Office | |
| August 2, 2024 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| 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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