FDA Inspection 934401 — American Red Cross Blood Services - Massachusetts Region
The FDA completed an inspection of American Red Cross Blood Services - Massachusetts Region on June 4, 2015 in Dedham, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 4, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Dedham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1218 | 21 CFR 211.67(b)(1) | Cleaning SOP/responsibility |
| 155 | 21 CFR 606.160(b) | Required records |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |