FDA Inspection 1238442 — Aurobindo Pharma USA Inc
The FDA completed an inspection of Aurobindo Pharma USA Inc on May 15, 2024 in East Windsor, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 15, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Windsor, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |
| 22933 | FDCA 582(b)(4)(B)(ii)(I) | Notify FDA and immediate trading partners of illegitimate product |