FDA Inspection 1083359 — HRF, Inc
The FDA completed an inspection of HRF, Inc on Mar 20, 2019 in Raleigh, NC. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 20, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Raleigh, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18085 | 21 CFR 630.10(f)(3) | Physical Assessment Determination - Hemoglobin or Hematocrit |
| 80 | 21 CFR 606.100(b)(1) | Donor criteria |
| 9076 | 21 CFR 600.12(a) | Maintenance - concurrence |