FOR IMMEDIATE RELEASE CIV WEDNESDAY, NOVEMBER 12, 1997 (202) 616-2765 TDD (202) 514-1888
DEPARTMENT OF JUSTICE SUES TEXAS MEDICAL GAS MANUFACTURER
WASHINGTON, D.C. -- The Department of Justice today asked a federal court to enjoin a Houston, Texas, company from producing and distributing medical gas, saying the company's manufacturing and installation procedures did not meet good manufacturing standards.
At the same time, the Department filed a proposed consent decree that would settle the case against Air Liquide America Corporation, which produces medical gases at approximately 75 U.S. facilities and serves more than 700 hospitals. The court must approve the proposal.
In a complaint filed on behalf of the Food and Drug Administration, the Department said Air Liquide America's medical gas production and delivery systems violated the Federal Food, Drug and Cosmetic Act because Air Liquide failed to adequately test its medical gas products and failed to adequately train technicians who installed the equipment in hospitals.
Assistant Attorney General Frank W. Hunger of the Civil Division said FDA investigators discovered the violations after inspecting 20 of Air Liquide America's medical gas facilities in California, Louisiana, Michigan and Texas. Air Liquide America is owned by Air Liquide, a French company that is the world's largest supplier of industrial gases.
"We must assure the quality and purity of all medical supplies used in a hospital, including gases," said Hunger. "Today's action aims to ensure that Air Liquide's handling of medical gases meets the FDA's standards."
Under the proposed consent decree, Air Liquide agreed to suspend production of medical gases until it properly validates the equipment it uses to test its finished product and to meet certain timetables for bringing other aspects of its operation into compliance with FDA regulations, the Department said.
The proposed injunction also would prohibit Air Liquide from installing new oxygen delivery systems at hospitals until FDA determines that the company is properly training its technicians and otherwise complying with current good manufacturing practices, according to the Department.
The FDA also would monitor Air Liquide America to ensure compliance and could order recalls or other remedial actions if necessary, the Department said.
The complaint and proposed settlement, filed in U.S. District Court in Houston, is the first addressing gas delivery systems at hospitals.