Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-21.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2026 – 21 Apr 2026 | Human Drugs | 483 | View 483 → |
| 26 Feb 2024 – 5 Mar 2024 | Human Drugs | Clean | |
| 24 Jun 2019 – 28 Jun 2019 | Human Drugs | 483 | On file |
| 30 Jan 2017 – 7 Feb 2017 | Human Drugs | 483 | View 483 → |
| 15 Mar 2015 – 20 Mar 2015 | Human Drugs | 483 | View 483 → |
| 6 Sep 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Apr 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tamil Arasu, Nibin Varghese
21 Apr 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Tamil Arasu, Nibin Varghese
Investigators
FDA investigators tied to this site in the record.
Tamil Arasu1 insp.
Nibin Varghese1 insp.
Vaishali J Patel1 insp.
Nicole E Knowlton1 insp.
Jose A Lopez Rubet1 insp.
Laurimer Kuilan-Torres1 insp.
Meisha R Sampson1 insp.
Andrew J Idzior1 insp.
Meisha R Waters1 insp.
Simone E Pitts1 insp.
Susanna E Ford1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | 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 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ajanta Pharma Ltd.'s 5 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