FDA Inspection 1201897 — Biomat USA Inc
The FDA completed an inspection of Biomat USA Inc on April 4, 2023 in Lafayette, LA. 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
- April 4, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lafayette, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9267 | 21 CFR 610.40(f) | Testing site |
| 98 | 21 CFR 606.100(c) | Thorough investigations |