FDA Inspection 818852 — Biomat USA Inc
The FDA completed an inspection of Biomat USA Inc on February 13, 2013 in Las Cruces, NM. 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 13, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Las Cruces, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 9236 | 21 CFR 630.40(b)(1) | Deferred or not eligible |
| 9243 | 21 CFR 630.40(a) | Notification |