FDA Inspection 1043565 — Biomat USA, Inc
The FDA completed an inspection of Biomat USA, Inc on March 8, 2018 in Houston, TX. 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
- March 8, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 18071 | 21 CFR 630.10(b) | Educational Material |