Sanofi
FDA inspection history in Framingham, Massachusetts, 2020 to 2025
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2020: one Form 483; 2022: one Form 483; 2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–25Three Form 483s and one warning letter, at Framingham, Massachusetts.
- 2024The longest 483 on file: 6 observations over 8 pages at Framingham, Massachusetts.
Cited most
Across all Sanofi observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.58Maintenance2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
The complete Sanofi file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Framingham, Massachusetts
Three Form 483s and one warning letter · 2020 to 2025 · 8 observations
Latest: Warning letter, Jan 15, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-15 | Warning letter Warning letter | Framingham, Massachusetts | — | $99 |
| 2024-07-09 | 483 Form 483 | Framingham, Massachusetts | 6 | $99 |
| 2022-07-25 | 483 Form 483 | Framingham, Massachusetts | 2 | $99 |
| 2020-09-04 | 483 Form 483 | Framingham, Massachusetts | — | $99 |
FEI number 1220423 · most recent document Jan 15, 2025
About Sanofi
How many FDA Form 483s has Sanofi received?
FDA Intel has 3 Form 483s on file for Sanofi; the most recent is dated Jul 9, 2024.
When was Sanofi last inspected by FDA?
The most recent FDA inspection document on file for Sanofi is a Form 483 dated Jul 9, 2024, for the site in Framingham, Massachusetts.
What did FDA cite at Sanofi?
The regulations cited most in the observations on file for Sanofi are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.58 (Maintenance), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.
Has Sanofi received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sanofi; the most recent is dated Jan 15, 2025.