FDA Inspection 1261299 — NuVida Medical LLC
The FDA completed an inspection of NuVida Medical LLC on Feb 19, 2025 in Phoenix, AZ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 19, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12421 | 21 CFR 1271.265(a) | Acceptance criteria designed to prevent CD |
| 12432 | 21 CFR 1271.265(e) | Documentation elements for activities |