Overview
- 11 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-24.
At a glance
Inspections
11
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Apr 2026 – 24 Apr 2026 | Human Drugs | Clean | |
| 9 Mar 2015 – 17 Mar 2015 | Human Drugs | 483 | View 483 → |
| 22 Jul 2013 – 31 Jul 2013 | Human Drugs | 483 | On file |
| 22 Apr 2013 – 26 Apr 2013 | Human Drugs | 483 | On file |
| 19 Apr 2013 – 25 Apr 2013 | Human Drugs | Clean | |
| 15 Apr 2013 – 25 Apr 2013 | Human Drugs | Clean | |
| 17 Dec 2010 | Not recorded | Clean | |
| 1 Feb 2008 | Not recorded | 483 | On file |
| 16 Nov 2005 | Not recorded | Clean | |
| 22 Jan 2004 | Not recorded | Clean | |
| 14 Mar 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Mar 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Eric M Mueller, Rafael E Arroyo
17 Mar 2015
21 CFR 211.160(b)(2)
In-process samples representative, identified properly
Cited by Eric M Mueller, Rafael E Arroyo
17 Mar 2015
21 CFR 211.180(e)(2)
Items to cover on annual reviews
Cited by Eric M Mueller, Rafael E Arroyo
17 Mar 2015
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Eric M Mueller, Rafael E Arroyo
Investigators
FDA investigators tied to this site in the record.
Gene R Gunn2 insp.
Tamil Arasu1 insp.
Nibin Varghese1 insp.
Eric M Mueller1 insp.
Rafael E Arroyo1 insp.
Dipesh K Shah1 insp.
Peter E Baker1 insp.
Atul Agrawal1 insp.
Susan D Yuscius1 insp.
Kham Phommachanh1 insp.
Barbara D Paul1 insp.
Regina T Brown1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Wockhardt Limited's 4 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