FDA Inspection 1027767 — Biomat USA Inc
The FDA completed an inspection of Biomat USA Inc on October 5, 2017 in Salem, OR. 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
- October 5, 2017
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Salem, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 333 | 21 CFR 640.64(e) | Prevention of contamination |