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ANI Pharmaceuticals Canada, Inc. FDA Record

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

Latest inspection VAI · Feb 17, 2023
No warning letters matched by name

Inspections 5

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

ANI Pharmaceuticals Canada, Inc. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "ANI Pharmaceuticals Canada, Inc." is on file.

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

Latest inspection: Feb 17, 2023 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	5	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

ANI Pharmaceuticals Canada, Inc.: FDA inspections per year

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	1	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	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

5 inspections from Dec 18, 2009 to Feb 17, 2023.

Date	Site	Product	Classification	FEI
Feb 17, 2023	Oakville, Canada	Drugs	Voluntary Action Indicated (VAI)	3002916530
Jun 7, 2019	Oakville, Canada	Drugs	Voluntary Action Indicated (VAI)	3002916530
Dec 9, 2016	Oakville, Canada	Drugs	Voluntary Action Indicated (VAI)	3002916530
Jan 24, 2014	Oakville, Canada	Drugs	Voluntary Action Indicated (VAI)	3002916530
Dec 18, 2009	Oakville, Canada	Drugs	Voluntary Action Indicated (VAI)	3002916530

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 3002916530	Oakville, Canada	5	Feb 17, 2023

ANI Pharmaceuticals Canada, Inc. and the FDA: common questions

Has ANI Pharmaceuticals Canada, Inc. received an FDA warning letter?

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

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

When did the FDA last inspect ANI Pharmaceuticals Canada, Inc.?

The most recent FDA inspection on file ended Feb 17, 2023 at Oakville, Canada and was classified VAI. FDA has 5 inspections of ANI Pharmaceuticals Canada, Inc. on file.

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