FDA Inspection 1310614 — Ionetix Corporation
The FDA completed an inspection of Ionetix Corporation on Apr 2, 2026 in Sarasota, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 2, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17760 | 21 CFR 212.20(c) | Specifications and processes |
| 17778 | 21 CFR 212.40(c) | Use of reliable suppliers |
| 17813 | 21 CFR 212.50(a) | Written control procedures |
| 21373 | 21 CFR 212.30(b) | Equipment procedures |