FDA Inspection 894213 — American Blood Bank Corp.
The FDA completed an inspection of American Blood Bank Corp. on Sep 26, 2014 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 26, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9266 | 21 CFR 610.40(e) | Further testing |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |