Sanofi Winthrop Industrie 1051 Boulevard Industriel
FDA inspection history in Le Trait, France, 2016 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2018: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Two Form 483s, at Le Trait, France.
- 2018The longest 483 on file: 11 observations over 7 pages at Le Trait, France.
- 2023One Form 483, at Le Trait, France.
Cited most
Across all Sanofi Winthrop Industrie 1051 Boulevard Industriel observations on file
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.122Materials examination and usage criteria1
- 21 CFR 211.130Packaging and labeling operations1
- 21 CFR 211.160General requirements1
The complete Sanofi Winthrop Industrie 1051 Boulevard Industriel file.
All 3 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
Le Trait, France
Three Form 483s · 2016 to 2023 · 18 observations
Latest: Form 483, Apr 25, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-25 | 483 Form 483 | Le Trait, France | 5 | $99 |
| 2018-05-25 | 483 Form 483 | Le Trait, France | 11 | $99 |
| 2016-07-19 | 483 Form 483 | Le Trait, France | 2 | $99 |
Investigators on these documents
Arie C. Menachem (1)Debra M. Emerson (1)Omotunde O. Osunsanmi (1)Prabhu P. Raju (1)Unnee Ranjan (1)
FEI number 3003259844 · most recent document Apr 25, 2023
About Sanofi Winthrop Industrie 1051 Boulevard Industriel
How many FDA Form 483s has Sanofi Winthrop Industrie 1051 Boulevard Industriel received?
FDA Intel has 3 Form 483s on file for Sanofi Winthrop Industrie 1051 Boulevard Industriel; the most recent is dated Apr 25, 2023.
When was Sanofi Winthrop Industrie 1051 Boulevard Industriel last inspected by FDA?
The most recent FDA inspection document on file for Sanofi Winthrop Industrie 1051 Boulevard Industriel is a Form 483 dated Apr 25, 2023, for the site in Le Trait, France.
What did FDA cite at Sanofi Winthrop Industrie 1051 Boulevard Industriel?
The regulations cited most in the observations on file for Sanofi Winthrop Industrie 1051 Boulevard Industriel are 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.122 (Materials examination and usage criteria), 1 time.