FDA Inspection 768701 — Banco De Sangre De Servicios Mutuos, Inc.
The FDA completed an inspection of Banco De Sangre De Servicios Mutuos, Inc. on Feb 21, 2012 in Fajardo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 21, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fajardo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |