Sanofi Pasteur Inc.
Form 483 issued August 2, 2024 · Swiftwater, Pennsylvania
- Inspection
- Jul 25 – Aug 2, 2024
- Observations
- 1
- Pages
- 3
- FEI number
- 2518760
In short: On August 2, 2024, FDA issued a Form 483 with 1 observation to Sanofi Pasteur Inc. in Swiftwater, Pennsylvania (FEI 2518760) after an inspection that ran Jul 25 – Aug 2, 2024. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Input to and output from related systems of formulas and records or data are…
This inspection in context
Questions about this 483
What did FDA find at Sanofi Pasteur Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Sanofi Pasteur Inc. inspected by FDA?
The inspection ran Jul 25 – Aug 2, 2024, and the Form 483 is dated August 2, 2024.
How do I get the full Form 483 for Sanofi Pasteur Inc.?
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