573528
Biomat USA, Inc. — FEI 3005524146
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 1, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Flint, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 9225 | 21 CFR 606.171 | Biological product deviation report |