Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-15.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2024 – 15 May 2024 | Human Drugs | 483 | On file |
| 1 Dec 2014 – 12 Dec 2014 | Human Drugs | Clean | |
| 30 May 2012 | Not recorded | Clean | |
| 29 Jul 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
15 May 2024
FDCA 582(b)(4)(A)
Systems in place to comply with verifciation requirements
Cited by Samir C Gala
15 May 2024
FDCA 582(b)(4)(B)(ii)(I)
Notify FDA and immediate trading partners of illegitimate product
Cited by Samir C Gala
15 May 2024
FDCA 582(b)(4)
Systems in place to comply with verifciation requirements
Cited by Samir C Gala
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4)(A) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4)(B)(ii)(I) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aurobindo Pharma USA Inc's 2 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