FDA Inspection 626356 — Biomat USA, Inc
The FDA completed an inspection of Biomat USA, Inc on October 22, 2009 in McAllen, 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
- October 22, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- McAllen, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 255 | 21 CFR 640.31 | Donor eligibility |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |