FDA Inspection 1017552 — American Red Cross Blood Services - Massachusetts Region
The FDA completed an inspection of American Red Cross Blood Services - Massachusetts Region on May 24, 2017 in Dedham, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 24, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Dedham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 155 | 21 CFR 606.160(b) | Required records |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |