Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-29.
At a glance
Inspections
7
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Sep 2023 – 29 Sep 2023 | Human Drugs | 483 | View 483 → |
| 28 Aug 2017 – 1 Sep 2017 | Human Drugs | 483 | On file |
| 1 Dec 2014 – 9 Dec 2014 | Human Drugs | Clean | |
| 21 Sep 2012 | Not recorded | 483 | View 483 → |
| 22 Dec 2010 | Not recorded | 483 | On file |
| 15 May 2007 | Not recorded | Clean | |
| 17 Nov 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jennifer L Huntington, Brandy N Lepage
21 Sep 2012
21 CFR 211.22(a)
Approve or reject components, products
Cited by Eileen A Liu, Torrance J Slayton, Stephen J Koniers
21 Sep 2012
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Eileen A Liu, Torrance J Slayton, Stephen J Koniers
21 Sep 2012
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Eileen A Liu, Torrance J Slayton, Stephen J Koniers
21 Sep 2012
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Eileen A Liu, Torrance J Slayton, Stephen J Koniers
Investigators
FDA investigators tied to this site in the record.
Jennifer L Huntington1 insp.
Brandy N Lepage1 insp.
Robert M Barbosa1 insp.
Yumi J Hiramine1 insp.
Eileen A Liu1 insp.
Torrance J Slayton1 insp.
Stephen J Koniers1 insp.
Mihaly S Ligmond1 insp.
Paul A Bonneau1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | 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 Aurobindo Pharma 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