Sanofi Winthrop Industrie
Form 483 issued July 17, 2018 · Aramon, France
- Inspection
- Jul 9 – Jul 17, 2018
- Investigator
- Gens Bumell M. Henry
- Observations
- 3
- Pages
- 4
- FEI number
- 3002808341
In short: On July 17, 2018, FDA issued a Form 483 with 3 observations to Sanofi Winthrop Industrie in Aramon, France (FEI 3002808341) after an inspection that ran Jul 9 – Jul 17, 2018. The investigator was Gens Bumell M. Henry. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and laboratory controls account for 2 of 3 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The process validation did not include controls for critical parameters necessary to ensure the (b) (…
- 02
Validated analytical methods for final product release testing are not sufficiently accurate and reproducible. The quality…
- 03
There is a failure to close out investigations in a timely manner. The following investigations have…
This inspection in context
Gens Bumell M. Henry
1 document · 2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in France.
The firmSanofi Winthrop Industrie history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanofi Winthrop Industrie?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sanofi Winthrop Industrie?
Gens Bumell M. Henry is named on this Form 483, for the inspection of Jul 9 – Jul 17, 2018. Each investigator has a profile showing what they cite most.
When was Sanofi Winthrop Industrie inspected by FDA?
The inspection ran Jul 9 – Jul 17, 2018, and the Form 483 is dated July 17, 2018.
How do I get the full Form 483 for Sanofi Winthrop Industrie?
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.