FDA Inspection 1098924 — American Blood Bank Corp.
The FDA completed an inspection of American Blood Bank Corp. on Aug 7, 2019 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
- Aug 7, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 18116 | 21 CFR 630.30(a)(3) | Donor medical history |
| 18118 | 21 CFR 630.30(b)(1) | Unsuitable donation - release |
| 224 | 21 CFR 640.4(f) | Arm preparation |