Sanofi Winthrop Industrie
FDA inspection history in Marcy L Etoile, France, 2017
- 1
- Form 483
Every document, by year
- Form 483
2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Marcy L Etoile, France.
Cited most
Across all Sanofi Winthrop Industrie observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.170Reserve samples1
The complete Sanofi Winthrop Industrie file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Marcy L Etoile, France
One Form 483 · 2017 · 9 observations
Latest: Form 483, Sep 27, 2017 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-09-27 | 483 Form 483 | Marcy L Etoile, France | 9 | $99 |
Investigators on these documents
Anissa M. Cheung (1)Michele L. Forster (1)Prabhu P. Raju (1)Scott E. Norris (1)
FEI number 3002972083 · most recent document Sep 27, 2017
About Sanofi Winthrop Industrie
How many FDA Form 483s has Sanofi Winthrop Industrie received?
FDA Intel has 1 Form 483 on file for Sanofi Winthrop Industrie; the most recent is dated Sep 27, 2017.
When was Sanofi Winthrop Industrie last inspected by FDA?
The most recent FDA inspection document on file for Sanofi Winthrop Industrie is a Form 483 dated Sep 27, 2017, for the site in Marcy L Etoile, France.
What did FDA cite at Sanofi Winthrop Industrie?
The regulations cited most in the observations on file for Sanofi Winthrop Industrie are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.