FDA Inspection 1118061 — Biomat USA, Inc
The FDA completed an inspection of Biomat USA, Inc on February 11, 2020 in Cincinnati, OH. 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
- February 11, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Cincinnati, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 333 | 21 CFR 640.64(e) | Prevention of contamination |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |