Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-21.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Mar 2025 – 21 Mar 2025 | Human Drugs | Clean | |
| 13 Jan 2020 – 17 Jan 2020 | Human Drugs | Clean | |
| 14 May 2018 – 18 May 2018 | Human Drugs | 483 | On file |
| 20 Apr 2015 – 23 Apr 2015 | Human Drugs | 483 | On file |
| 1 Apr 2013 – 5 Apr 2013 | Human Drugs | 483 | On file |
| 10 Feb 2011 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Samir C Gala1 insp.
Anastasia M Shields1 insp.
Ko U Min1 insp.
Tracy K Li1 insp.
James L Dunnie1 insp.
Jose R Hernandez1 insp.
Daniel J Lahar1 insp.
Ivis L Negron Torres1 insp.
Full site report
Get the verbatim findings behind Alembic Pharmaceuticals Limited's 3 Form 483s
The full inspection record, as Atlas holds it, 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