FDA Inspection 1096232 — University Of Michigan Hospital and Health Centers
The FDA completed an inspection of University Of Michigan Hospital and Health Centers on July 11, 2019 in Ann Arbor, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
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 |