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Emergent BioSolutions Canada Inc., Winnipeg, Canada – FDA Inspections

Inspection records and compliance data for Emergent BioSolutions Canada Inc. in Winnipeg, R3T. 9 FDA inspections on record, 4 Form 483s, last inspected May 12, 2026.

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Company Profile

This profile covers Emergent BioSolutions Canada Inc. based in Winnipeg, R3T, Canada.

FDA Inspection History

FDA inspections
9
OAI
0
VAI
7
NAI
0
Unclassified
2
Form 483s
4
Warning letters
0

First inspected April 22, 2010. Last inspected May 12, 2026.

Most cited issue areas

  • Authority lacking to review records, investigate errors1 inspection
  • Calibration/Inspection/Checking not done1 inspection
  • Changes to Procedures Not Reviewed, Approved1 inspection

FDA inspections (9)

DateResultFDA center(s)Insp. #
May 12, 2026Not classifiedBiologics · Blood and Blood Products1316698
August 27, 2025Not classifiedHuman Drugs1280431
September 13, 2019VAIHuman Drugs · Drug Quality Assurance1109095
May 16, 2017VAIBiologics · Blood and Blood Products1018375
February 3, 2015VAIHuman Drugs · Drug Quality Assurance918929
July 18, 2014VAIBiologics · Blood and Blood Products905505
June 21, 2012VAIBiologics · Blood and Blood Products798543
October 19, 2011VAIHuman Drugs · Drug Quality Assurance772122
April 22, 2010VAIBiologics · Blood and Blood Products660837
FDA documents

Form 483s (7)

  • Form 483s · May 12, 2026
  • Form 483s · August 27, 2025
  • Form 483s · May 10, 2022
  • Form 483s · September 13, 2019
  • Form 483s · May 16, 2017
  • Form 483s · July 18, 2014
  • Form 483s · June 12, 2012

EIRs (2)

  • EIRs · September 13, 2019
  • EIRs · May 16, 2017
Other regulators (1)
  • Health Canada · 6 inspections · last February 24, 2026
People (6)
Laurimer Kuilan-Torres
Person
Laurimer X. Kauian-Torres
Person
Prabhu P. Raju
Person
Burnell M. Henry
Person
Debra M. Emerson
Person
Linda Thai
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Catalent Indiana, LLC
Catalent Belgium SA
Naari Pharma Private Limited
Resilience Biotechnologies, Inc.
Patheon Manufacturing Services LLC
Confab Laboratories Inc.
Bora Pharmaceuticals Injectables Inc
Jubilant HollisterStier General Partnership
Jubilant HollisterStier LLC
Hospira, Inc., A Pfizer Company
Company Information

Name

Emergent BioSolutions Canada Inc.

FEI Number

3003153579

Canada Business Number

885463950RC0006

Address

155 Innovation Dr, Winnipeg, R3T 5Y3, Canada

Country

Canada

ID: b307e34c-3470-4633-86ab-237341dae46c

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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