FDA Inspection 1102159 — Laboratorio Banco Vida
The FDA completed an inspection of Laboratorio Banco Vida on September 18, 2019 in San Juan, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 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 |
|---|---|---|
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12342 | 21 CFR 1271.190(a) | Size, construction, location--prevent mix-ups etc. |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |