FDA Inspection 1102613 — Innovative Transfusion Medicine, Inc.
The FDA completed an inspection of Innovative Transfusion Medicine, Inc. on September 19, 2019 in Miami Lakes, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 18097 | 21 CFR 630.10(h) | Ineligible Donor |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |