FDA Inspection 792654 — Banco De Sangre De Servicios Mutuos Inc.-Centro De Coleccion Bayamon
The FDA completed an inspection of Banco De Sangre De Servicios Mutuos Inc.-Centro De Coleccion Bayamon on Jul 31, 2012 in Bayamon, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 31, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bayamon, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 82 | 21 CFR 606.100(b)(3) | Preparation of phlebotomy site |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |