Sanofi Winthrop Industrie
Form 483 issued September 27, 2017 · Marcy L Etoile, France
- Inspection
- Sep 18 – Sep 27, 2017
- Investigators
- Anissa M. Cheung· Michele L. Forster· Prabhu P. Raju
- Observations
- 9
- Pages
- 7
- FEI number
- 3002972083
In short: On September 27, 2017, FDA issued a Form 483 with 9 observations to Sanofi Winthrop Industrie in Marcy L Etoile, France (FEI 3002972083) after an inspection that ran Sep 18 – Sep 27, 2017. The investigators were Anissa M. Cheung, Michele L. Forster, Prabhu P. Raju and Scott E. Norris. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 6 of 9 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
Deficiencies were observed in the stability program of the final…
- 02
Procedures ‘designed to prevent microbiological contamination of drug products purporting to be sterile…
- 03
The following Serious Adverse Events were submitted in excess of 15 calendar days due to the…
- 04
The rationale for not initiating Corrective and Preventive Action (CAPA) and/or follow up actions (i.e. awareness…
This inspection in context
Anissa M. Cheung
7 documents · 2017–2024
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanofi Winthrop Industrie?
FDA listed 9 observations on this Form 483, mostly about production, quality system and laboratory controls. 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?
Anissa M. Cheung, Michele L. Forster, Prabhu P. Raju and Scott E. Norris are named on this Form 483, for the inspection of Sep 18 – Sep 27, 2017. Each investigator has a profile showing what they cite most.
When was Sanofi Winthrop Industrie inspected by FDA?
The inspection ran Sep 18 – Sep 27, 2017, and the Form 483 is dated September 27, 2017.
How do I get the full Form 483 for Sanofi Winthrop Industrie?
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