FDA Inspection 1096232 — University Of Michigan Hospital And Health Centers
The FDA completed an inspection of University Of Michigan Hospital And Health Centers on Jul 11, 2019 in Ann Arbor, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 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 |