FDA Inspection 853846 — Biomat USA, Inc.
The FDA completed an inspection of Biomat USA, Inc. on November 1, 2013 in Kennewick, WA. 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
- November 1, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Kennewick, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9235 | 21 CFR 630.40(c) | Documentation |
| 9305 | 21 CFR 640.66 | Procedures |