FDA Inspection 1293728 — Biomat USA Inc
The FDA completed an inspection of Biomat USA Inc on February 4, 2026 in Surprise, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 4, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Surprise, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 88 | 21 CFR 606.100(b)(9) | Written methods for investigating adverse reactions |