599890
Biolife, LLC — FEI 3003395204
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 31, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |