Drug factory · FDA FEI 3013422537

Ionetix Corporation

1950 S Tamiami Trail, Sarasota, FL, United States

Problems found, fixed voluntarily at FDA's last inspection, Apr 2, 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 2019: 0 with no problems, 2 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

Ended	Result	Program	Problems noted
Apr 2, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	4
Oct 25, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Specifications and processes 21 CFR 212.20(c)
You did not approve or reject, before implementation, specifications to ensure that they maintain the identity, strength, quality, and purity of a PET drug.
Equipment procedures 21 CFR 212.30(b)
You did not implement procedures and document your activities in accordance with your procedures to ensure that all equipment is suitable for its intended purposes and properly installed, maintained, and capable of repeatedly producing valid results that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained.
Use of reliable suppliers 21 CFR 212.40(c)
You did not use a reliable supplier as a source of each lot of component.
Written control procedures 21 CFR 212.50(a)
You did not have written production and process control procedures to ensure that any deviations from the procedures are justified.

Registered with FDA for: positron emission tomography drug production.