Sanofi Pasteur Inc.
Form 483 issued June 15, 2018 · Swiftwater, Pennsylvania
- Inspection
- Jun 6 – Jun 15, 2018
- Investigators
- Cynthia Jim· Justin A. Boyd
- Observations
- 14
- Pages
- 10
- FEI number
- 2518760
In short: On June 15, 2018, FDA issued a Form 483 with 14 observations to Sanofi Pasteur Inc. in Swiftwater, Pennsylvania (FEI 2518760) after an inspection that ran Jun 6 – Jun 15, 2018. The investigators were Cynthia Jim and Justin A. Boyd. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.113 (3×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is insufficient separation of filling…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do…
- 03
The qualification of operators working on Building…
- 04
Records do not include complete data derived from all tests, examinations and assay necessary to assure…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanofi Pasteur Inc.?
FDA listed 14 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sanofi Pasteur Inc.?
Cynthia Jim and Justin A. Boyd are named on this Form 483, for the inspection of Jun 6 – Jun 15, 2018. Each investigator has a profile showing what they cite most.
When was Sanofi Pasteur Inc. inspected by FDA?
The inspection ran Jun 6 – Jun 15, 2018, and the Form 483 is dated June 15, 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.