FDA Inspection 1208880 — KEDPLASMA LLC
The FDA completed an inspection of KEDPLASMA LLC on June 26, 2023 in Sanford, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 26, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sanford, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 338 | 21 CFR 640.65(b)(2)(i) | Physician review of four month sample |