FDA Inspection 1283830 — Ionetix Corporation
The FDA completed an inspection of Ionetix Corporation on Sep 26, 2025 in Miami Beach, 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
- Sep 26, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17722 | 21 CFR 212.10 | Lack Adequate Resources, Facilities, Equipment. |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17778 | 21 CFR 212.40(c) | Use of reliable suppliers |
| 21373 | 21 CFR 212.30(b) | Equipment procedures |
| 21374 | 21 CFR 212.40(a) | Written procedures for control of components, containers, and closures |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |