FDA Inspection 1282496 — Barbara Ann Karmanos Cancer Hospital
The FDA completed an inspection of Barbara Ann Karmanos Cancer Hospital on September 19, 2025 in Detroit, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Detroit, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17812 | 21 CFR 212.50 | Adequate controls (general) |
| 17886 | 21 CFR 212.70(e) | When 30 hour rule is exceeded |