FDA Inspection 1255957 — Novo Nordisk Inc.
The FDA completed an inspection of Novo Nordisk Inc. on February 7, 2025 in Plainsboro, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 7, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Plainsboro, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 18025 | 21 CFR 314.80(c)(2)(ii)(B) | Late submission of an ICSR |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6735 | 21 CFR 314.80(c)(1)(ii) | Failure to investigate serious, unexpected events |