FDA Inspection 1082112 — Division Of Nuclear Medicine PET Radiopharmaceutical Production Program
The FDA completed an inspection of Division Of Nuclear Medicine PET Radiopharmaceutical Production Program on Mar 7, 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 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 |