FDA Inspection 943168 — Allied Biomedical Research Institute, Inc.
The FDA completed an inspection of Allied Biomedical Research Institute, Inc. on September 11, 2015 in Miami, FL. 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
- September 11, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 116 | 21 CFR 606.121(e) | Container label requirements - particular products |
| 9269 | 21 CFR 610.40(h) | Shipment/use of reactive units, units from deferred donors |
| 9270 | 21 CFR 610.40(h)(2)(ii) | Labeling of reactive units, units from deferred donors |