FDA Inspection 1210014 — Northland Nuclear Medicine, LLC
The FDA completed an inspection of Northland Nuclear Medicine, LLC on July 13, 2023 in Bismarck, ND. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 13, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bismarck, ND (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17812 | 21 CFR 212.50 | Adequate controls (general) |
| 17821 | 21 CFR 212.50(b)(6) | Action limits on radiochemical yield |
| 21373 | 21 CFR 212.30(b) | Equipment procedures |