Sanofi Winthrop Industrie 1051 Boulevard Industriel
Form 483 issued July 19, 2016 · Le Trait, France
- Inspection
- Jul 7 – Jul 19, 2016
- Investigators
- Arie C. Menachem· Debra M. Emerson
- Observations
- 2
- Pages
- 9
- FEI number
- 3003259844
In short: On July 19, 2016, FDA issued a Form 483 with 2 observations to Sanofi Winthrop Industrie 1051 Boulevard Industriel in Le Trait, France (FEI 3003259844) after an inspection that ran Jul 7 – Jul 19, 2016. The investigators were Arie C. Menachem and Debra M. Emerson. Most observations concern quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.180 (1×) · 314.81 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm has repeatedly refused to provide the requested. documentation for review of the CBER regulated…
- 02
The firm does not have a thorough understanding of the requirements for submission of OM ried…
This inspection in context
Arie C. Menachem
5 documents · 2015–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmSanofi Winthrop Industrie 1051 Boulevard Industriel history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanofi Winthrop Industrie 1051 Boulevard Industriel?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Sanofi Winthrop Industrie 1051 Boulevard Industriel?
Arie C. Menachem and Debra M. Emerson are named on this Form 483, for the inspection of Jul 7 – Jul 19, 2016. Each investigator has a profile showing what they cite most.
When was Sanofi Winthrop Industrie 1051 Boulevard Industriel inspected by FDA?
The inspection ran Jul 7 – Jul 19, 2016, and the Form 483 is dated July 19, 2016.
How do I get the full Form 483 for Sanofi Winthrop Industrie 1051 Boulevard Industriel?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.