FDA Inspection 1268434 — Ionetix Corporation
The FDA completed an inspection of Ionetix Corporation on May 1, 2025 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 1, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17722 | 21 CFR 212.10 | Lack Adequate Resources, Facilities, Equipment. |
| 17851 | 21 CFR 212.60(c) | Analytical methods |
| 17898 | 21 CFR 212.71(c) | Correction of problems |
| 21373 | 21 CFR 212.30(b) | Equipment procedures |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |