Overview
- 9 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-17.
At a glance
Inspections
9
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Apr 2026 – 17 Apr 2026 | Human Drugs | 483 | On file |
| 8 Nov 2022 – 17 Nov 2022 | Human Drugs | 483 | View 483 → |
| 9 Sep 2019 – 17 Sep 2019 | Human Drugs | 483 | On file |
| 24 Jul 2017 – 2 Aug 2017 | Human Drugs | 483 | View 483 → |
| 1 Jun 2016 – 10 Jun 2016 | Human Drugs | WL | View 483 → |
| 19 Mar 2015 – 27 Mar 2015 | Human Drugs | 483 | View 483 → |
| 29 Aug 2013 – 6 Sep 2013 | Human Drugs | 483 | View 483 → |
| 14 Oct 2012 | Not recorded | 483 | View 483 → |
| 25 Dec 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Nov 2022
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Saleem A Akhtar, Kellia N Hicks
17 Nov 2022
21 CFR 211.110(b)
In-process materials specifications testing
Cited by Saleem A Akhtar, Kellia N Hicks
17 Nov 2022
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Saleem A Akhtar, Kellia N Hicks
17 Nov 2022
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Saleem A Akhtar, Kellia N Hicks
Investigators
FDA investigators tied to this site in the record.
Lisa L Flores1 insp.
Rafeeq A Habeeb1 insp.
Saleem A Akhtar1 insp.
Kellia N Hicks1 insp.
Tamil Arasu1 insp.
Jogy George1 insp.
Christopher D Leach1 insp.
Anita Narula1 insp.
Xiaokuang Lai1 insp.
Dipesh K Shah1 insp.
Daniel J Roberts1 insp.
Carla J Lundi1 insp.
Santos E Camara1 insp.
Blondell W Johnson1 insp.
Edmund F Mrak1 insp.
Mural B Gavini1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind USV Private Limited's 9 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