Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
APAurobindo Pharma USA IncEast Windsor, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 3 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere