FDA Inspection 897378 — Octapharma Plasma, Inc.
The FDA completed an inspection of Octapharma Plasma, Inc. on Sep 24, 2014 in Lynchburg, VA. 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
- Sep 24, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lynchburg, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 9225 | 21 CFR 606.171 | Biological product deviation report |