Sanofi Winthrop Industrie 1051 Boulevard Industriel
Form 483 issued May 25, 2018 · Le Trait, France
- Inspection
- May 16 – May 25, 2018
- Investigator
- Omotunde O. Osunsanmi
- Observations
- 11
- Pages
- 7
- FEI number
- 3003259844
In short: On May 25, 2018, FDA issued a Form 483 with 11 observations to Sanofi Winthrop Industrie 1051 Boulevard Industriel in Le Trait, France (FEI 3003259844) after an inspection that ran May 16 – May 25, 2018. The investigator was Omotunde O. Osunsanmi. Most observations concern facilities & equipment and packaging & labeling; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and packaging & labeling account for 7 of 11 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not __…
This inspection in context
Omotunde O. Osunsanmi
13 documents · 2003–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in United Kingdom.
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 211.42
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 11 observations on this Form 483, mostly about facilities & equipment, packaging & labeling and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Sanofi Winthrop Industrie 1051 Boulevard Industriel?
Omotunde O. Osunsanmi is named on this Form 483, for the inspection of May 16 – May 25, 2018. Each investigator has a profile showing what they cite most.
When was Sanofi Winthrop Industrie 1051 Boulevard Industriel inspected by FDA?
The inspection ran May 16 – May 25, 2018, and the Form 483 is dated May 25, 2018.
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.