FDA Inspection 788124 — Rhode Island Blood Center, A Division Of New York Blood Center, Inc.
The FDA completed an inspection of Rhode Island Blood Center, A Division Of New York Blood Center, Inc. on Jun 21, 2012 in Providence, RI. 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). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 21, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Providence, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 155 | 21 CFR 606.160(b) | Required records |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 63 | 21 CFR 606.65 | Safe, sanitary, orderly storage |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 9256 | 21 CFR 610.41 | Donor Deferral |