Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-23.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Jun 2023 – 23 Jun 2023 | Human Drugs | Clean | |
| 5 Sep 2022 – 9 Sep 2022 | Human Drugs | 483 | View 483 → |
| 17 Jun 2019 – 22 Jun 2019 | Human Drugs | 483 | On file |
| 23 Jul 2018 – 27 Jul 2018 | Human Drugs | Clean | |
| 5 Feb 2018 – 9 Feb 2018 | Human Drugs | Clean | |
| 3 Apr 2017 – 7 Apr 2017 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Michele Gottshall1 insp.
Joel D Hustedt1 insp.
Jose M Cayuela1 insp.
Ariel Cruz Figueroa1 insp.
Sangeeta M Khurana1 insp.
Jai P Singh1 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 | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ajanta Pharma 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