FDA Inspection 1217728 — Ionetix Corporation
The FDA completed an inspection of Ionetix Corporation on September 14, 2023 in El Paso, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- El Paso, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17850 | 21 CFR 212.60(b) | Lab sampling and test procedures |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |