Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-05-06.
At a glance
Inspections
3
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Apr 2022 – 6 May 2022 | Human Drugs | 483 | View 483 → |
| 4 Dec 2017 – 12 Dec 2017 | Human Drugs | WL | View 483 → |
| 3 Nov 2014 – 6 Nov 2014 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 May 2022
21 CFR 211.125(c)
Label reconciliation discrepancies evaluation/investigation
Cited by Alan P Kurtzberg
12 Dec 2017
21 CFR 211.166(a)
Results not used for expiration dates, storage cond.
Cited by Linda F Murphy
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lernapharm (Loris) Inc.'s 2 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat