Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-10.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Feb 2023 – 10 Feb 2023 | Human Drugs | 483 | View 483 → |
| 4 Nov 2019 – 8 Nov 2019 | Human Drugs | 483 | View 483 → |
| 26 Feb 2018 – 1 Mar 2018 | Human Drugs | Clean | |
| 15 May 2017 – 19 May 2017 | Human Drugs | Clean | |
| 28 Nov 2016 – 1 Dec 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Feb 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Wayne D Mcgrath, Dennis Cantellops Paite
10 Feb 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Wayne D Mcgrath, Dennis Cantellops Paite
10 Feb 2023
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Wayne D Mcgrath, Dennis Cantellops Paite
10 Feb 2023
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Wayne D Mcgrath, Dennis Cantellops Paite
8 Nov 2019
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by William J Leonard, Haitao Li
Investigators
FDA investigators tied to this site in the record.
Wayne D Mcgrath1 insp.
Dennis Cantellops Paite1 insp.
William J Leonard1 insp.
Haitao Li1 insp.
Samina S Khan1 insp.
Azza Talaat1 insp.
Ariel Cruz Figueroa1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Laurus Labs Limited's 3 Form 483s
Source PDFs 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