FDA Inspection 1082533 — Biomat USA Inc
The FDA completed an inspection of Biomat USA Inc on March 14, 2019 in Nashville, TN. 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
- March 14, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Nashville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9225 | 21 CFR 606.171 | Biological product deviation report |