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•United States

Sanofi Vaccines US Inc., Swiftwater, PA – FDA Inspections

Inspection records and compliance data for Sanofi Vaccines US Inc. in Swiftwater, Pennsylvania. 12 FDA inspections on record, 5 Form 483s, last inspected August 20, 2026.

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Company Profile

This profile covers Sanofi Vaccines US Inc. based in Swiftwater, Pennsylvania, United States.

FDA Inspection History

FDA inspections
12
OAI
0
VAI
8
NAI
1
Unclassified
3
Form 483s
5
Warning letters
0

First inspected April 21, 2009. Last inspected August 20, 2026.

Most cited issue areas

  • Air Supply1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection
  • Equipment Design, Size and Location1 inspection

FDA inspections (12)

DateResultFDA center(s)Insp. #
August 20, 2026Not classifiedBiologics, Human Drugs · Drug Quality Assurance1328608
November 6, 2025Not classifiedBiologics1298398
August 2, 2024VAIBiologics · Vaccines and Allergenic Products1229985
April 22, 2023VAIHuman Drugs · Drug Quality Assurance1205715
October 26, 2018Not classifiedBiologics1076207
June 15, 2018NAIBiologics, Human Drugs · Drug Quality Assurance1056859
June 22, 2016VAIBiologics · Vaccines and Allergenic Products981571
May 9, 2014VAIBiologics · Vaccines and Allergenic Products899677
August 18, 2012VAIBiologics · Vaccines and Allergenic Products798121
May 21, 2010VAIBiologics · Vaccines and Allergenic Products682725
November 5, 2009VAIBiologics · Vaccines and Allergenic Products627292
April 21, 2009VAIBiologics · Vaccines and Allergenic Products595048
FDA documents

Form 483s (7)

  • Form 483s · November 6, 2025
  • Form 483s · August 2, 2024
  • Form 483s · January 26, 2024
  • Form 483s · April 22, 2023
  • Form 483s · April 28, 2006
  • Form 483s
  • Form 483s

EIRs (2)

  • EIRs · April 22, 2023
  • EIRs · October 26, 2018
Other regulators (1)
  • UK MHRA · 1 inspection · last September 24, 2018
People (5)
Edmund F. Mrak
Person
Susan M. Jackson
Person
Damon A. Growl
Person
Solomon Yimam
Person
Susan King
Person
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Company Information

Name

Sanofi Vaccines US Inc.

FEI Number

2518760

Address

1 Discovery Dr, Swiftwater, Pennsylvania 18370, United States

Country

United States

ID: 94f5ecde-ae72-47f6-b6b7-ca9126ef544f

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🇪🇺+48 532-447-507
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