FDA Inspection 836735 — Physician's Plasma Alliance Inc.
The FDA completed an inspection of Physician's Plasma Alliance Inc. on Jun 11, 2013 in Johnson City, TN. 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
- Jun 11, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Johnson City, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 205 | 21 CFR 640.3(f) | Donations in less than eight weeks |
| 338 | 21 CFR 640.65(b)(2)(i) | Physician review of four month sample |