Sanofi Pasteur Inc.
FDA inspection history in Swiftwater, Pennsylvania, 2006 to 2024
- 5
- Form 483s
Every document, by year
- Form 483
2006: one Form 483; 2018: two Form 483s; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2006One Form 483, at Swiftwater, Pennsylvania.
- 2018Two Form 483s, at Swiftwater, Pennsylvania.
- 2018The longest 483 on file: 14 observations over 10 pages at Swiftwater, Pennsylvania.
- 2023–24Two Form 483s, at Swiftwater, Pennsylvania.
Cited most
Across all Sanofi Pasteur observations on file
- 21 CFR 211.113Control of microbiological contamination10
- 21 CFR 211.192Production record review7
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.160General requirements4
- 21 CFR 211.110Sampling and testing of in-process materials and drug products3
The complete Sanofi Pasteur file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Swiftwater, Pennsylvania
Five Form 483s · 2006 to 2024 · 29 observations
Latest: Form 483, Aug 2, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-02 | 483 Form 483 | Swiftwater, Pennsylvania | 1 | $99 |
| 2023-04-22 | 483 Form 483 | Swiftwater, Pennsylvania | 3 | $99 |
| 2018-10-26 | 483 Form 483 | Swiftwater, Pennsylvania | 2 | $99 |
| 2018-06-15 | 483 Form 483 | Swiftwater, Pennsylvania | 14 | $99 |
| 2006-04-28 | 483 Form 483 | Swiftwater, Pennsylvania | 9 | $99 |
Investigators on these documents
Ann Marie Montemurro (1)Christian Lynch (1)Cynthia Jim (1)Dino Feigelstock (1)Edmund F. Mrak (1)Justin A. Boyd (1)Mihaly S. Ligmond (1)Robert Sausville (1)Solomon Yimam (1)Tina Roecklein (1)Willie Vann (1)
FEI number 2518760 · most recent document Aug 2, 2024
About Sanofi Pasteur Inc.
How many FDA Form 483s has Sanofi Pasteur Inc. received?
FDA Intel has 5 Form 483s on file for Sanofi Pasteur Inc.; the most recent is dated Aug 2, 2024.
When was Sanofi Pasteur Inc. last inspected by FDA?
The most recent FDA inspection document on file for Sanofi Pasteur Inc. is a Form 483 dated Aug 2, 2024, for the site in Swiftwater, Pennsylvania.
What did FDA cite at Sanofi Pasteur Inc.?
The regulations cited most in the observations on file for Sanofi Pasteur Inc. are 21 CFR 211.113 (Control of microbiological contamination), 10 times; 21 CFR 211.192 (Production record review), 7 times; 21 CFR 211.42 (Design and construction features), 6 times.