FDA Inspection 1232771 — Jubilant DraxImage Radiopharmacies Inc.
The FDA completed an inspection of Jubilant DraxImage Radiopharmacies Inc. on Mar 13, 2024 in Orlando, FL. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 13, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18945 | FDCA 501(a)(2)(A) | Aseptic processing outside ISO 5 area |
| 22744 | FDCA 501(a)(2)(A) | Personnel, blocked or disrupted first air |
| 22758 | FDCA 501(a)(2)(A) | Non-sterile disinfecting agents, ISO 5 area/classified areas |
| 22763 | FDCA 501(a)(2)(A) | Lack of/inadequate, environmental monitoring |
| 22766 | FDCA 501(a)(2)(A) | Inadequate smoke studies |
| 22769 | FDCA 501(a)(2)(A) | Media fills, failure |