Overview
- 8 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-05.
At a glance
Inspections
8
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2025 – 5 Sep 2025 | Human Drugs | 483 | On file |
| 10 Feb 2020 – 21 Feb 2020 | Human Drugs | 483 | On file |
| 5 Mar 2018 – 16 Mar 2018 | Human Drugs | 483 | View 483 → |
| 2 Jul 2015 – 10 Jul 2015 | Human Drugs | 483 | On file |
| 12 Aug 2013 – 16 Aug 2013 | Human Drugs | Clean | |
| 26 Jun 2012 | Not recorded | 483 | On file |
| 17 Sep 2010 | Not recorded | 483 | On file |
| 9 Apr 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Mar 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Debra I Love, Philip F Istafanos
16 Mar 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Debra I Love, Philip F Istafanos
9 Apr 2009
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Susan M Jackson, Michele Perry Williams
Investigators
FDA investigators tied to this site in the record.
Eileen A Liu1 insp.
Claudia M Perez-Kasmarski1 insp.
Joseph A Piechocki1 insp.
Frederick Razzaghi1 insp.
Xiaokuang Lai1 insp.
Debra I Love1 insp.
Philip F Istafanos1 insp.
Tamil Arasu1 insp.
Thomas J Arista1 insp.
Eric M Mueller1 insp.
Parul M Patel1 insp.
Demitria J Xiradakis1 insp.
Barbara M Frazier1 insp.
Susan M Jackson1 insp.
Michele Perry Williams1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aurobindo Pharma Limited's 7 Form 483s
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