FDA Inspection 1056542 — BPC Plasma, Inc.
The FDA completed an inspection of BPC Plasma, Inc. on Jun 22, 2018 in Norcross, GA. 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 22, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Norcross, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18104 | 21 CFR 630.15(b)(1)(ii) | Donor deferral if at risk from procedure |
| 9243 | 21 CFR 630.40(a) | Notification |