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Emergent BioSolutions Canada Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Emergent BioSolutions Canada Inc. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Emergent BioSolutions Canada Inc." is on file. FDA has published 1 Form 483 for Emergent BioSolutions Canada Inc..

What these totals cover: FDA records filed under the name "Emergent BioSolutions Canada Inc." and its spelling variant "Emergent Biosolutions Canada".

Latest inspection: Sep 13, 2019 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	7	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Emergent BioSolutions Canada Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Emergent BioSolutions Canada Inc. Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Sep 13, 2019 · Document on fda.gov	483	3003153579

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

7 inspections from Apr 22, 2010 to Sep 13, 2019.

Date	Site	Product	Classification	FEI
Sep 13, 2019	Winnipeg, Canada	Drugs	Voluntary Action Indicated (VAI)	3003153579
May 16, 2017	Winnipeg, Canada	Biologics	Voluntary Action Indicated (VAI)	3003153579
Feb 3, 2015	Winnipeg, Canada	Drugs	Voluntary Action Indicated (VAI)	3003153579
Jul 18, 2014	Winnipeg, Canada	Biologics	Voluntary Action Indicated (VAI)	3003153579
Jun 21, 2012	Winnipeg, Canada	Biologics	Voluntary Action Indicated (VAI)	3003153579
Oct 19, 2011	Winnipeg, Canada	Drugs	Voluntary Action Indicated (VAI)	3003153579
Apr 22, 2010	Winnipeg, Canada	Biologics	Voluntary Action Indicated (VAI)	3003153579

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003153579	Winnipeg, Canada	7	Sep 13, 2019

Emergent BioSolutions Canada Inc. and the FDA: common questions

Has Emergent BioSolutions Canada Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Emergent BioSolutions Canada Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Emergent BioSolutions Canada Inc. received an FDA Form 483?

FDA has published 1 Form 483 for Emergent BioSolutions Canada Inc. in its reading room, the most recent dated Sep 13, 2019. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Emergent BioSolutions Canada Inc.?

The most recent FDA inspection on file ended Sep 13, 2019 at Winnipeg, Canada and was classified VAI. FDA has 7 inspections of Emergent BioSolutions Canada Inc. on file.

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