FDA Inspection 939664 — Biomat USA, Inc.
The FDA completed an inspection of Biomat USA, Inc. on July 31, 2015 in El Paso, 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
- July 31, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- El Paso, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |