Sanofi Pasteur Inc.
Form 483 issued October 26, 2018 · Swiftwater, Pennsylvania
- Inspection
- Oct 22 – Oct 26, 2018
- Investigators
- Christian Lynch· Dino Feigelstock· Solomon Yimam
- Observations
- 2
- Pages
- 1
- FEI number
- 2518760
In short: On October 26, 2018, FDA issued a Form 483 with 2 observations to Sanofi Pasteur Inc. in Swiftwater, Pennsylvania (FEI 2518760) after an inspection that ran Oct 22 – Oct 26, 2018. The investigators were Christian Lynch, Dino Feigelstock and Solomon Yimam. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures regarding YF-VAX production…
- 02
(b) (4) cycle failures associated with the Line (b) (4) are not…
This inspection in context
Christian Lynch
4 documents · 2016–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New Hampshire.
The firmSanofi Pasteur Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanofi Pasteur Inc.?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Sanofi Pasteur Inc.?
Christian Lynch, Dino Feigelstock and Solomon Yimam are named on this Form 483, for the inspection of Oct 22 – Oct 26, 2018. Each investigator has a profile showing what they cite most.
When was Sanofi Pasteur Inc. inspected by FDA?
The inspection ran Oct 22 – Oct 26, 2018, and the Form 483 is dated October 26, 2018.
How do I get the full Form 483 for Sanofi Pasteur Inc.?
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.