Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-26.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jul 2024 – 26 Jul 2024 | Human Drugs | Clean | |
| 9 Mar 2020 – 13 Mar 2020 | Human Drugs | 483 | On file |
| 22 Oct 2018 – 26 Oct 2018 | Human Drugs | 483 | View 483 → |
| 12 Mar 2018 – 20 Mar 2018 | Human Drugs | 483 | View 483 → |
| 21 Mar 2016 – 25 Mar 2016 | Human Drugs | 483 | View 483 → |
| 16 Feb 2015 – 20 Feb 2015 | Human Drugs | Clean | |
| 30 Aug 2012 | Not recorded | 483 | View 483 → |
| 15 May 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Oct 2018
21 CFR 211.188(b)(5)
In-process and laboratory control results
Cited by Jogy George, Haitao Li
26 Oct 2018
21 CFR 211.188(b)(5)
In-process and laboratory control results
Cited by Jogy George, Haitao Li
Investigators
FDA investigators tied to this site in the record.
Christina K Theodorou1 insp.
Cynthia Jim1 insp.
Shirshendu K Deb1 insp.
Jogy George1 insp.
Haitao Li1 insp.
Jessica L Pressley1 insp.
Erika V Butler1 insp.
Zhaoyang Meng1 insp.
Jason K Morgan1 insp.
Nicole E Knowlton1 insp.
Walden H Lee1 insp.
Michael A Charles1 insp.
Pankaj H Amin1 insp.
Mural B Gavini1 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 | 7x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alembic Pharmaceuticals 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