FDA inspection
Sanofi Pasteur Inc.: FDA inspection ending Oct 26, 2018
FDA inspection 1076207 · Voluntary Action Indicated (VAI) · Swiftwater, PA
Key facts
| Inspection ID | 1076207 |
|---|---|
| Firm | Sanofi Pasteur Inc. |
| FEI number | 2518760 |
| Address | 1 Discovery Dr |
| City | Swiftwater |
| State | PA |
| ZIP | 18370-9100 |
| Fiscal year | 2019 |
| Inspection end date | Oct 26, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic 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| Product type | Biologics, Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 10–99 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data