Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-20.
At a glance
Inspections
10
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 May 2025 – 20 May 2025 | Human Drugs | 483 | View 483 → |
| 13 Jan 2020 – 23 Jan 2020 | Human Drugs | 483 | View 483 → |
| 16 Apr 2018 – 26 Apr 2018 | Human Drugs | Clean | |
| 3 Oct 2016 – 7 Oct 2016 | Human Drugs | 483 | On file |
| 20 Jun 2016 – 24 Jun 2016 | Human Drugs | Clean | |
| 13 Jul 2015 – 21 Jul 2015 | Human Drugs | 483 | On file |
| 10 Mar 2014 – 14 Mar 2014 | Human Drugs | 483 | View 483 → |
| 8 Feb 2012 | Not recorded | 483 | On file |
| 2 Feb 2011 | Not recorded | Clean | |
| 28 Jun 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 May 2025
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Tamil Arasu, Lauren N Howard
20 May 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tamil Arasu, Lauren N Howard
23 Jan 2020
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Arsen Karapetyan
Investigators
FDA investigators tied to this site in the record.
Tamil Arasu1 insp.
Lauren N Howard1 insp.
Arsen Karapetyan1 insp.
Ariel Cruz Figueroa1 insp.
Ademola O Daramola1 insp.
James L Dunnie1 insp.
Lucas B Leake1 insp.
Justin A Boyd1 insp.
Mural B Gavini1 insp.
William A Warnick1 insp.
Katherine Szestypalow1 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 | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | 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 Watson Pharma Private 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