Sanofi Pasteur Inc.
Form 483 issued April 28, 2006 · Swiftwater, Pennsylvania
- Inspection
- Apr 18 – Apr 28, 2006
- Investigators
- Ann Marie Montemurro· Mihaly S. Ligmond· Robert Sausville
- Observations
- 27
- Pages
- 8
- FEI number
- 2518760
In short: On April 28, 2006, FDA issued a Form 483 with 27 observations to Sanofi Pasteur Inc. in Swiftwater, Pennsylvania (FEI 2518760) after an inspection that ran Apr 18 – Apr 28, 2006. The investigators were Ann Marie Montemurro, Mihaly S. Ligmond, Robert Sausville, Tina Roecklein and Willie Vann. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (7×) · 211.192 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
There is no assurance that the wet/dry vacuum used for cleaning the floors of classified production…
- 03
Observation 3: scanned text, readable in the full document.
- 04
There is no assurance that training / qualification of all operators performing aseptic operations in the…
This inspection in context
Ann Marie Montemurro
1 document · 2006
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
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 27 observations on this Form 483, mostly about production, quality system and laboratory controls. 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.?
Ann Marie Montemurro, Mihaly S. Ligmond, Robert Sausville, Tina Roecklein and Willie Vann are named on this Form 483, for the inspection of Apr 18 – Apr 28, 2006. Each investigator has a profile showing what they cite most.
When was Sanofi Pasteur Inc. inspected by FDA?
The inspection ran Apr 18 – Apr 28, 2006, and the Form 483 is dated April 28, 2006.
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.