FDA Inspection 1015511 — Banco de Sangre ASEM
The FDA completed an inspection of Banco de Sangre ASEM on June 22, 2017 in San Juan, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 22, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |