FDA Inspection 750971 — Banco De Sangre De Servicios Mutuos, Inc.
The FDA completed an inspection of Banco De Sangre De Servicios Mutuos, Inc. on Oct 19, 2011 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 19, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 106 | 21 CFR 606.120(a) | Separation of labeling operations |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 157 | 21 CFR 606.160(d) | Retention period |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9077 | 21 CFR 600.12(a) | Maintenance - completeness |
| 98 | 21 CFR 606.100(c) | Thorough investigations |