FDA Inspection 981304 — Innovative Transfusion Medicine, Inc.
The FDA completed an inspection of Innovative Transfusion Medicine, Inc. on July 8, 2016 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 8, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 18080 | 21 CFR 630.10(e) | Medical History Interview |
| 18096 | 21 CFR 630.10(g)(2)(ii) | Donor's Acknowledgment - Exculpatory language |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |