Drug factory · FDA FEI 3009211584

University of California, Los Angeles

780 WESTWOOD PLZ, Los Angeles, CA, United States

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

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

4 drug inspections on record since 2012: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Gallium Ga-68 Gozetotide	Makes it	UCLA Biomedical Cyclotron	76394-2642

Ended	Result	Program	Problems noted
Jul 31, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	3
Jul 31, 2020	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 2, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	6
Aug 24, 2012	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, processes or procedures to ensure that they maintain the identity, strength, quality, and purity of a PET drug.
Supplies adequately controlled 21 CFR 212.60(d)
Your quality of supplies used in your testing procedures are not adequately controlled.
Conform to specs prior to release 21 CFR 212.70(c)
You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug product conforms to specifications before final release.

Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch failed to meet specifications, you did not determine the need for an investigation, conduct an investigation and take appropriate corrective actions when necessary.
Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures.
Contamination, mix-ups and deterioration 21 CFR 212.40(d)
You did not handle and store components, containers and closures in a manner that prevents contamination and deterioration and ensures that they are and remain suitable for their intended use.
Complete instructions, procedures, specs 21 CFR 212.50(b)(7)
Your master production and control records did not contain complete production and control instructions, complete sampling and testing procedures and complete specifications.
Results of investigations 21 CFR 212.50(c)(11)
Your batch production and control records did not include the results of any investigations conducted.
Complete record of all laboratory test data 21 CFR 212.60(g)(3)
Laboratory records did not contain a complete record of all data obtained in the course of each test.

Registered with FDA for: positron emission tomography drug production.