Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-15.
At a glance
Inspections
6
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jul 2024 – 15 Jul 2024 | Human Drugs | 483 | View 483 → |
| 22 Jul 2019 – 31 Jul 2019 | Human Drugs | 483 | On file |
| 14 Mar 2017 – 20 Mar 2017 | Human Drugs | 483 | On file |
| 13 Apr 2015 – 17 Apr 2015 | Human Drugs | 483 | View 483 → |
| 6 Apr 2012 | Not recorded | 483 | On file |
| 15 May 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jul 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Wayne D Mcgrath, Saleem A Akhtar
15 Jul 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Wayne D Mcgrath, Saleem A Akhtar
15 Jul 2024
21 CFR 211.68(b)
Computer control of master formula records
Cited by Wayne D Mcgrath, Saleem A Akhtar
Investigators
FDA investigators tied to this site in the record.
Wayne D Mcgrath1 insp.
Saleem A Akhtar1 insp.
Adetutu M Gidado1 insp.
Mathew T Thomas1 insp.
Daniel J Roberts1 insp.
Scott T Ballard1 insp.
Gregson A Joseph1 insp.
Felix Maldonado1 insp.
Gwyn G Dickinson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Unichem Laboratories Limited's 6 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