FDA Inspection 1003089 — Octapharma Plasma Inc.
The FDA completed an inspection of Octapharma Plasma Inc. on March 2, 2017 in Maple Heights, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 2, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Maple Heights, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 36 | 21 CFR 606.40 | Suitable size, construction, etc. |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |