FDA Inspection 1078696 — Barbara Ann Karmanos Cancer Hospital
The FDA completed an inspection of Barbara Ann Karmanos Cancer Hospital on February 4, 2019 in Detroit, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 4, 2019
- Fiscal Year
- 2019
- 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 |
| 17849 | 21 CFR 212.60(a) | Testing procedures |