Lernapharm (Loris) Inc.
Form 483 issued May 6, 2022 · St. Laurent, Canada
- Inspection
- Apr 28 – May 6, 2022
- Investigator
- Alan P. Kurtzberg
- Observations
- 2
- Pages
- 2
- FEI number
- 3004158845
In short: On May 6, 2022, FDA issued a Form 483 with 2 observations to Lernapharm (Loris) Inc. in St. Laurent, Quebec (FEI 3004158845) after an inspection that ran Apr 28 – May 6, 2022. The investigator was Alan P. Kurtzberg. Most observations concern packaging & labeling and laboratory controls; the most-cited regulation is 21 CFR 211.125 (labeling issuance).
At a glance
Packaging & labeling and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.125(c) (1×) · 211.165(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmLernapharm (Loris) Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.125(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lernapharm (Loris) Inc.?
FDA listed 2 observations on this Form 483, mostly about packaging & labeling and laboratory controls. The most-cited regulation is 21 CFR 211.125 (labeling issuance). The opening words of each observation are shown on this page.
Who inspected Lernapharm (Loris) Inc.?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Apr 28 – May 6, 2022. Each investigator has a profile showing what they cite most.
When was Lernapharm (Loris) Inc. inspected by FDA?
The inspection ran Apr 28 – May 6, 2022, and the Form 483 is dated May 6, 2022.
How do I get the full Form 483 for Lernapharm (Loris) Inc.?
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