Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-07-21.
At a glance
Inspections
11
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jul 2023 – 21 Jul 2023 | Human Drugs | 483 | View 483 → |
| 13 May 2019 – 24 May 2019 | Human Drugs | 483 | View 483 → |
| 6 Aug 2018 – 10 Aug 2018 | Human Drugs | 483 | View 483 → |
| 10 Apr 2017 – 18 Apr 2017 | Human Drugs | 483 | View 483 → |
| 25 Jan 2016 – 29 Jan 2016 | Human Drugs | Clean | |
| 18 Jun 2015 – 26 Jun 2015 | Human Drugs | 483 | View 483 → |
| 2 Mar 2012 | Not recorded | Clean | |
| 8 Sep 2011 | Not recorded | 483 | View 483 → |
| 24 Sep 2010 | Not recorded | Clean | |
| 22 Oct 2009 | Not recorded | Clean | |
| 30 Jan 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jul 2023
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Anastasia M Shields, Andrew Le
21 Jul 2023
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Anastasia M Shields, Andrew Le
21 Jul 2023
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Anastasia M Shields, Andrew Le
Investigators
FDA investigators tied to this site in the record.
Anastasia M Shields1 insp.
Andrew Le1 insp.
Arsen Karapetyan1 insp.
Jennifer C Adams1 insp.
Courtney N Long1 insp.
Angela E Glenn1 insp.
Cheryl A Clausen1 insp.
Helen Verdel1 insp.
Sangeeta M Khurana1 insp.
Pratik S Upadhyay1 insp.
S. L Brown1 insp.
Stacey S Degarmo1 insp.
Barbara M Frazier1 insp.
Matthew B Casale1 insp.
Parul M Patel1 insp.
Sharon K Thoma1 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 | 3x |
| 21 CFR 211.113(a) | 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) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | 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 211.137(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(a) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aurobindo Pharma 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