Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-08.
At a glance
Inspections
7
Form 483s
5
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Nov 2022 – 8 Dec 2022 | Human Drugs | Clean | |
| 30 Jun 2019 – 11 Jul 2019 | Human Drugs | 483 | View 483 → |
| 29 Jan 2017 – 5 Feb 2017 | Human Drugs | 483 | On file |
| 17 May 2015 – 21 May 2015 | Human Drugs | 483 | View 483 → |
| 28 May 2010 | Not recorded | 483 | On file |
| 10 Sep 2009 | Not recorded | 483 | On file |
| 31 Oct 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jul 2019
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Yvesna C Blaise, Walden H Lee
21 May 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Leonard H Lavi, Sandra A Hughes
21 May 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Leonard H Lavi, Sandra A Hughes
21 May 2015
21 CFR 211.194(a)
Complete test data included in records
Cited by Leonard H Lavi, Sandra A Hughes
21 May 2015
21 CFR 211.194(a)
Complete test data included in records
Cited by Leonard H Lavi, Sandra A Hughes
Investigators
FDA investigators tied to this site in the record.
Norman K Starks1 insp.
Michael Araneta1 insp.
Yvesna C Blaise1 insp.
Walden H Lee1 insp.
Zhongren Wu1 insp.
Pratik S Upadhyay1 insp.
Leonard H Lavi1 insp.
Sandra A Hughes1 insp.
Simone E Pitts1 insp.
Jose A Lopez Rubet1 insp.
Margaret M Annes1 insp.
Cynthia J Lee1 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 | 2x |
| 21 CFR 211.194(a) | 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(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Taro Pharmaceutical Industries 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