Sanofi Winthrop Industrie
Form 483 issued June 15, 2018 · Tours, France
- Inspection
- Jun 11 – Jun 15, 2018
- Investigator
- Rajiv R. Srivastava
- Observations
- 1
- Pages
- 1
- FEI number
- 3003282644
In short: On June 15, 2018, FDA issued a Form 483 with 1 observation to Sanofi Winthrop Industrie in Tours, Centre (FEI 3003282644) after an inspection that ran Jun 11 – Jun 15, 2018. The investigator was Rajiv R. Srivastava. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSanofi Winthrop Industrie history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanofi Winthrop Industrie?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Sanofi Winthrop Industrie?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Jun 11 – Jun 15, 2018. Each investigator has a profile showing what they cite most.
When was Sanofi Winthrop Industrie inspected by FDA?
The inspection ran Jun 11 – Jun 15, 2018, and the Form 483 is dated June 15, 2018.
How do I get the full Form 483 for Sanofi Winthrop Industrie?
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