FDA Inspection 1039470 — BPL Plasma, Inc.
The FDA completed an inspection of BPL Plasma, Inc. on Feb 2, 2018 in Austin, TX. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 2, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15033 | 21 CFR 610.47(a) | Lookback System [Collecting Establishment] |
| 9089 | 21 CFR 600.14(c) | When to report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |