Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-22.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Nov 2024 – 22 Nov 2024 | Human Drugs | 483 | View 483 → |
| 8 Dec 2022 – 16 Dec 2022 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Nov 2024
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Teresa I Navas
Investigators
FDA investigators tied to this site in the record.
Teresa I Navas1 insp.
Marcellinus D Dordunoo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | 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 Alembic Pharmaceuticals Limited's 2 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