FDA Inspection 1242579 — Innovative Transfusion Medicine, Inc.
The FDA completed an inspection of Innovative Transfusion Medicine, Inc. on Oct 7, 2024 in Miami Lakes, 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
- Oct 7, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15034 | 21 CFR 610.47(a)(1) | Review Records ID Previous Donations [Collecting Estab] |
| 15065 | 21 CFR 610.46(a)(1) | Review Records to ID Previous Donations [Collecting Estab] |
| 155 | 21 CFR 606.160(b) | Required records |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |