FDA Inspection 981277 — Biomat USA Inc
The FDA completed an inspection of Biomat USA Inc on June 21, 2016 in Lakewood, CO. 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
- June 21, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lakewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 9243 | 21 CFR 630.40(a) | Notification |