Drug factory · FDA FEI 3008674916

The Methodist Hospital Research Institute

6670 Bertner Avenue, Houston, TX, United States

Problems found, fixed voluntarily at FDA's last inspection, Feb 13, 2026.

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

3 drug inspections on record since 2014: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Ammonia N-13	Makes it	The Methodist Hospital Research Institute	69864-002
Fludeoxyglucose F-18	Makes it	The Methodist Hospital Research Institute	69864-001

Ended	Result	Program	Problems noted
Feb 13, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	4
Nov 2, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	6
Aug 7, 2014	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 has the identity and strength that it is supposed to have and meets the quality and purity characteristics that it is supposed to have.
Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures.
Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is cleaned 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.
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.

Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and 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.
Complete instructions, procedures, specs 21 CFR 212.50(b)(7)
Your master production and control records did not include complete production and control instructions and precautions to be followed.
Testing procedures 21 CFR 212.60(a)
Each laboratory used to conduct testing of finished PET drug products does not have written procedures for the conduct of each test.
Complete record of all laboratory test data 21 CFR 212.60(g)(3)
Laboratory test records did not contain a complete record of all data obtained in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, in-process material, or drug product for each lot tested.
Correction of problems 21 CFR 212.71(c)
You did not take appropriate action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem.

Registered with FDA for: positron emission tomography drug production.