FDA Inspection 1088733 — Octapharma Plasma, Inc.
The FDA completed an inspection of Octapharma Plasma, Inc. on May 2, 2019 in Dallas, TX. 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
- May 2, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18082 | 21 CFR 630.10(e)(2) | Additional Medical Assessment Factors |