Drug factory · FDA FEI 3016458643

Ionetix Corporation

7812 Gateway Blvd E Ste 120, El Paso, TX, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 14, 2023.

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 2023: 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 14, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	2

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

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.
Lab sampling and test procedures 21 CFR 212.60(b)
Each laboratory did not have testing procedures which are designed to ensure that components, in-process materials and PET drug products conform to appropriate standards including established standards of identity, strength, quality and purity.

Registered with FDA for: positron emission tomography drug production.