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Lernapharm (Loris) Inc. FDA Inspection Record

FEI 3004158845 · Inspections, Form 483s, warning letters and import refusals

Lernapharm (Loris) Inc. is an FDA-registered facility (FEI 3004158845) located in SAINT-LAURENT Quebec, CA. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
May 6, 2022: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 OAI, 1 VAI, 1 NAI)
Last OAI inspection
Dec 12, 2017
Warning letters
1 listed by FDA for this FEI, latest Sep 4, 2018
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 6, 2022Voluntary Action Indicated (VAI)Label reconciliation discrepancies evaluation/investigation (21 CFR 211.125(c))
Testing and release for distribution (21 CFR 211.165(a))
Dec 12, 2017Official Action Indicated (OAI)Reprocessing procedures not written or followed (21 CFR 211.115(a))
Valid stability test methods (21 CFR 211.166(a)(3))
Sterility/pyrogen-free testing (21 CFR 211.167(a))
Investigations of discrepancies, failures (21 CFR 211.192)
and 2 more
Nov 6, 2014No Action Indicated (NAI)No citations listed

FDA record score

19 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

4 records behind this number
RecordDatePoints x age weightAdds
Warning letter on FDA's dashboard, which does not show close-outsSep 4, 201830 x 0.257.5
Inspection classified OAIDec 12, 201730 x 0.257.5
Inspection classified VAIMay 6, 20226 x 0.63.6
12 import refusals in 2020Dec 31, 20202 x 0.250.5

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Lernapharm (Loris) Inc.
Location
SAINT-LAURENT Quebec (CA)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
both

Compliance actions

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.