Drug factory · FDA FEI 3016460801
Ionetix
200 Lothrop Street Rm A332, Pittsburgh, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 19, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ammonia N-13 | Makes it | Ionetix Corporation | 71162-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 19, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 19, 2024 inspection
- Contact surfaces 21 CFR 212.30(c)
Your equipment is not constructed so that surfaces that contact components, in-process materials and PET drugs are not reactive, additive, or absorptive so as to alter the quality of the PET drugs.
Registered with FDA for: positron emission tomography drug production.