FDA Inspection 980945 — American Blood Bank Corp.
The FDA completed an inspection of American Blood Bank Corp. on May 19, 2016 in Miami, FL. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 19, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 98 | 21 CFR 606.100(c) | Thorough investigations |