FDA Inspection 994704 — Kedplasma LLC
The FDA completed an inspection of Kedplasma LLC on Nov 21, 2016 in Hot Springs, AR. 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
- Nov 21, 2016
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hot Springs, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 36 | 21 CFR 606.40 | Suitable size, construction, etc. |