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Delpharm Boucherville Canada, Inc. FDA Record

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

Delpharm Boucherville Canada, Inc. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Delpharm Boucherville Canada, Inc." is on file.

What these totals cover: FDA records filed under the name "Delpharm Boucherville Canada, Inc." and its spelling variant "Delpharm Boucherville Canada".

Latest inspection: Jan 26, 2024 · 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

Delpharm Boucherville 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	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	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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Recent FDA inspections

7 inspections from Jul 15, 2009 to Jan 26, 2024.

Date	Site	Product	Classification	FEI
Jan 26, 2024	Boucherville, Canada	Drugs	Voluntary Action Indicated (VAI)	3000280957
Feb 11, 2020	Boucherville, Canada	Drugs	No Action Indicated (NAI)	3000280957
Jun 12, 2018	Boucherville, Canada	Drugs	No Action Indicated (NAI)	3000280957
Aug 9, 2016	Boucherville, Canada	Drugs	No Action Indicated (NAI)	3000280957
Oct 22, 2013	Boucherville, Canada	Drugs	Voluntary Action Indicated (VAI)	3000280957
Aug 4, 2011	Boucherville, Canada	Drugs	Official Action Indicated (OAI)	3000280957
Jul 15, 2009	Boucherville, Canada	Drugs	Voluntary Action Indicated (VAI)	3000280957

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 3000280957	Boucherville, Canada	7	Jan 26, 2024

Delpharm Boucherville Canada, Inc. and the FDA: common questions

Has Delpharm Boucherville Canada, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Delpharm Boucherville 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 Delpharm Boucherville Canada, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Delpharm Boucherville Canada, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Delpharm Boucherville Canada, Inc.?

The most recent FDA inspection on file ended Jan 26, 2024 at Boucherville, Canada and was classified VAI. FDA has 7 inspections of Delpharm Boucherville Canada, Inc. on file, 1 of them classified OAI (official action indicated).

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