FDA Inspection 1102161 — Banco Vida Corp.
The FDA completed an inspection of Banco Vida Corp. on Sep 18, 2019 in San Juan, PR. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 18, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |