Drug factory · FDA FEI 3022114900

Ionetix Corporation

300 W 41st St, , Suite 101, Miami Beach, FL, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 26, 2025.

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 2025: 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

Ended	Result	Program	Problems noted
Sep 26, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	6

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

Lack Adequate Resources, Facilities, Equipment. 21 CFR 212.10
You lack adequate resources and equipment to enable your personnel to perform their functions.
Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures.
Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.
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.
Written procedures for control of components, containers, and closures 21 CFR 212.40(a)
You did not follow written procedures describing the testing of components, drug product containers and closures.
Use of reliable suppliers 21 CFR 212.40(c)
You did not use a reliable supplier as a source of each lot of component.

Registered with FDA for: positron emission tomography drug production.