Drug factory · FDA FEI 3008927689

University of Texas MD Anderson Cancer Center

1881 East Road, Unit 1903, Houston, TX, United States

Problems found, fixed voluntarily at FDA's last inspection, Feb 24, 2026.

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 2013: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Fludeoxyglucose F-18	Makes it	The University of Texas MD Anderson Cancer Center	60215-411

Ended	Result	Program	Problems noted
Feb 24, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	4
Mar 20, 2018	Problems found, fixed voluntarily	Bioresearch Monitoring	3
Jul 25, 2016	No problems found	Drug Quality Assurance	—
Sep 16, 2013	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.

Oversight of production operations 21 CFR 212.20(a)
You did not oversee production operations in a manner to ensure that each PET drug meets the quality and purity characteristics that it is supposed to have.
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.
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.
ID of major equipment 21 CFR 212.50(c)(7)
Your batch production record did not include the identification of major pieces of equipment used in production of the batch.

Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the evaluation of post marketing adverse drug experiences.
Late submission of quarterly safety reports 21 CFR 314.80(c)(2)
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.
Timely submission 21 CFR 314.81(b)(2)
An annual report was not submitted within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.

Registered with FDA for: positron emission tomography drug production.