1096232
University Of Michigan Hospital and Health Centers — FEI 3008453145
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 11, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12402 | 21 CFR 1271.230(c) | Changes to validated process |
| 12440 | 21 CFR 1271.270(b) | Prompt retrieval from multiple locations |