1059476
BioEden Inc — FEI 3005877419
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 19, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |