Sanofi Winthrop Industrie
Form 483 issued February 18, 2020 · Lyon, France
- Inspection
- Feb 10 – Feb 18, 2020
- Investigators
- Debra M. Emerson· Eileen A. Liu
- Observations
- 5
- Pages
- 4
- FEI number
- 3009194033
In short: On February 18, 2020, FDA issued a Form 483 with 5 observations to Sanofi Winthrop Industrie in Lyon, France (FEI 3009194033) after an inspection that ran Feb 10 – Feb 18, 2020. The investigators were Debra M. Emerson and Eileen A. Liu. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system 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
There is a failure to ensure adequate controls for the accuracy of data and to…
- 02
Quality Assurance (QA} unit did not fulfill its responsibility to fully review and investigate…
- 03
Manufacturing areas are deficient regarding the system…
- 04
The design of the washing cabinet used to clean equipment for the manufacture of Thymoglobulin…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSanofi Winthrop Industrie history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanofi Winthrop Industrie?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Sanofi Winthrop Industrie?
Debra M. Emerson and Eileen A. Liu are named on this Form 483, for the inspection of Feb 10 – Feb 18, 2020. Each investigator has a profile showing what they cite most.
When was Sanofi Winthrop Industrie inspected by FDA?
The inspection ran Feb 10 – Feb 18, 2020, and the Form 483 is dated February 18, 2020.
How do I get the full Form 483 for Sanofi Winthrop Industrie?
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