FDA Inspection 909274 — Jubilant Draximage Radiopharmacies Inc
The FDA completed an inspection of Jubilant Draximage Radiopharmacies Inc on Jan 9, 2015 in Kansas City, MO. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 9, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |