FDA Inspection 747581 — Biomat USA, Inc.
The FDA completed an inspection of Biomat USA, Inc. on September 22, 2011 in Flint, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 22, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Flint, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 80 | 21 CFR 606.100(b)(1) | Donor criteria |