Sanofi Pasteur Limited
Form 483 issued October 11, 2019 · North York, Canada
- Inspection
- Oct 7 – Oct 11, 2019
- Investigators
- Anita Verma· Donald L. Lech· Joan Johnson
- Observations
- 1
- Pages
- 2
- FEI number
- 3002888623
In short: On October 11, 2019, FDA issued a Form 483 with 1 observation to Sanofi Pasteur Limited in North York, Canada (FEI 3002888623) after an inspection that ran Oct 7 – Oct 11, 2019. The investigators were Anita Verma, Donald L. Lech, Joan Johnson and Leslie Wagner. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm failed to maintain Building) used for the manufacture (b) (4), in a clean and…
This inspection in context
Anita Verma
1 document · 2019
Cites 211.56 (sanitation) more than any other section. Most of their documents are for sites in Canada.
The firmSanofi Pasteur Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanofi Pasteur Limited?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Sanofi Pasteur Limited?
Anita Verma, Donald L. Lech, Joan Johnson and Leslie Wagner are named on this Form 483, for the inspection of Oct 7 – Oct 11, 2019. Each investigator has a profile showing what they cite most.
When was Sanofi Pasteur Limited inspected by FDA?
The inspection ran Oct 7 – Oct 11, 2019, and the Form 483 is dated October 11, 2019.
How do I get the full Form 483 for Sanofi Pasteur Limited?
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.