Drug factory · FDA FEI 3015287791
Ionetix Corporation
261 Old York Rd, Suite 108, Jenkintown, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 23, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2021: 1 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 |
|---|---|---|---|
| Jul 23, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 30, 2021 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 23, 2026 inspection
- Non-Conforming Product Investigation Incomplete 21 CFR 212.71(a)
The investigation of the cause of the nonconforming batch of a PET drug product did not include examination of the processes, operations, records and other relevant sources of information concerning the nonconforming product.
Registered with FDA for: positron emission tomography drug production.