FDA Inspection 1073344 — Biomat USA, Inc
The FDA completed an inspection of Biomat USA, Inc on December 3, 2018 in Arlington, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 3, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Arlington, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9052 | 21 CFR 600.11(b) | Equipment |
| 9078 | 21 CFR 600.12(a) | Maintenance - tracing |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9241 | 21 CFR 630.40(a) | Supplemental results |