FDA Inspection 1172604 — Innovative Transfusion Medicine, Inc.
The FDA completed an inspection of Innovative Transfusion Medicine, Inc. on June 24, 2022 in Miami Lakes, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 24, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Miami Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 18068 | 21 CFR 630.5(d) | CPR certification |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |