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Lernapharm (Loris) Inc. FDA Record

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

Latest inspection VAI · May 6, 2022
Last warning letter 2018

Inspections 3

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Sep 4, 2018

510(k) clearances 0 None on file

Lernapharm (Loris) Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Lernapharm (Loris) Inc., the most recent on Sep 4, 2018.

What these totals cover: FDA records filed under the name "Lernapharm (Loris) Inc." and its spelling variant "Lernapharm (Loris)".

Latest inspection: May 6, 2022 · 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	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Lernapharm (Loris) Inc.: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	1	0	0
2021	0	0	0
2020	0	0	0
2019	0	0	0
2018	0	0	1
2017	1	1	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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Lernapharm (Loris) Inc. FDA Warning Letters

1 warning letter on Sep 4, 2018.

Issued	Subject	Issuing office	Close-out letter
Sep 4, 2018 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

3 inspections from Nov 6, 2014 to May 6, 2022.

Date	Site	Product	Classification	FEI
May 6, 2022	Saint-Laurent, Canada	Drugs	Voluntary Action Indicated (VAI)	3004158845
Dec 12, 2017	Saint-Laurent, Canada	Drugs	Official Action Indicated (OAI)	3004158845
Nov 6, 2014	Saint-Laurent, Canada	Drugs	No Action Indicated (NAI)	3004158845

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Lernapharm (Loris) Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 4, 2018.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3004158845	Saint-Laurent, Canada	3	May 6, 2022

Lernapharm (Loris) Inc. and the FDA: common questions

Has Lernapharm (Loris) Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Lernapharm (Loris) Inc.. The most recent is dated Sep 4, 2018.

Has Lernapharm (Loris) Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Lernapharm (Loris) Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Lernapharm (Loris) Inc.?

The most recent FDA inspection on file ended May 6, 2022 at Saint-Laurent, Canada and was classified VAI. FDA has 3 inspections of Lernapharm (Loris) Inc. on file, 1 of them classified OAI (official action indicated).

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