1082112
Division of Nuclear Medicine PET Radiopharmaceutical Production Program — FEI 3010166888
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 7, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17784 | 21 CFR 212.40(c)(2) | Rep.sample - containers/closures |
| 17896 | 21 CFR 212.71(a) | Rejection of nonconforming product |