FDA Inspection 1231263 — Cone Health
The FDA completed an inspection of Cone Health on Feb 27, 2024 in Greensboro, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 27, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Greensboro, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 149 | 21 CFR 606.151(e) | Procedures to expedite transfusions in emergencies |
| 155 | 21 CFR 606.160(b) | Required records |