Sanofi Pasteur Inc.
Form 483 issued April 22, 2023 · Swiftwater, Pennsylvania
- Inspection
- Mar 20 – Apr 22, 2023
- Investigator
- Edmund F. Mrak
- Observations
- 3
- Pages
- 5
- FEI number
- 2518760
In short: On April 22, 2023, FDA issued a Form 483 with 3 observations to Sanofi Pasteur Inc. in Swiftwater, Pennsylvania (FEI 2518760) after an inspection that ran Mar 20 – Apr 22, 2023. The investigator was Edmund F. Mrak. Most observations concern facilities & equipment.
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 03
Aseptic processing areas are deficient regarding air supply that is (D) (4) through high-efficiency particulate air…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanofi Pasteur Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sanofi Pasteur Inc.?
Edmund F. Mrak is named on this Form 483, for the inspection of Mar 20 – Apr 22, 2023. Each investigator has a profile showing what they cite most.
When was Sanofi Pasteur Inc. inspected by FDA?
The inspection ran Mar 20 – Apr 22, 2023, and the Form 483 is dated April 22, 2023.
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.