Sanofi Winthrop Industrie 1051 Boulevard Industriel
Form 483 issued April 25, 2023 · Le Trait, France
- Inspection
- Apr 17 – Apr 25, 2023
- Investigators
- Prabhu P. Raju· Unnee Ranjan
- Observations
- 5
- Pages
- 6
- FEI number
- 3003259844
In short: On April 25, 2023, FDA issued a Form 483 with 5 observations to Sanofi Winthrop Industrie 1051 Boulevard Industriel in Le Trait, France (FEI 3003259844) after an inspection that ran Apr 17 – Apr 25, 2023. The investigators were Prabhu P. Raju and Unnee Ranjan. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with cGMP…
- 03
Samples taken of drug products for determination of conformance to written…
- 04
Procedures to prevent microbiological contamination of products purporting to be sterile did not include adequate validation…
This inspection in context
Prabhu P. Raju
21 documents · 2008–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in France.
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 211.22
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 5 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Sanofi Winthrop Industrie 1051 Boulevard Industriel?
Prabhu P. Raju and Unnee Ranjan are named on this Form 483, for the inspection of Apr 17 – Apr 25, 2023. Each investigator has a profile showing what they cite most.
When was Sanofi Winthrop Industrie 1051 Boulevard Industriel inspected by FDA?
The inspection ran Apr 17 – Apr 25, 2023, and the Form 483 is dated April 25, 2023.
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.