Drug factory · FDA FEI 3015265824

Ionetix Corporation

3901 Rainbow Blvd, Suite B701, Kansas City, KS, United States

Problems found, fixed voluntarily at FDA's last inspection, Oct 31, 2025.

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

Ended	Result	Program	Problems noted
Oct 31, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	4
Feb 25, 2021	No problems found	Drug Quality Assurance	—

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

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 to ensure that all equipment is suitable for its intended purposes 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.
Adequate controls (general) 21 CFR 212.50
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.

Registered with FDA for: positron emission tomography drug production.