June 25, 2002–COATESVILLE, PA–The U.S. Food and Drug Administration has shut down certain operations of Air Liquide America Corp.’s medical gas facility here for failing to assure that its industrial-grade trailers, which are used to store and haul medical gases, were clean, purged and completely free of contaminants prior to being filled.

“This enforcement action is part of FDA’s commitment to ensure compliance with rules that protect the lives and health of consumers,” said FDA Deputy Commissioner Lester M. Crawford. “Practices that may endanger the public health cannot be tolerated.”

Air Liquide had agreed to comply with FDA product safety regulations, current Good Manufacturing Practices (cGMPs) in a consent decree signed in November, 1997, but during three separate inspections in April the FDA found that the Coatesville facility had failed to meet the agreed upon standards.

As a result, the FDA ordered Air Liquide to immediately stop filling trailers and distributing medical gases.
Crawford says the greatest concern is that the use of trailers that have not been properly sanitized could result in a contaminated medical gas. The consequences of inhaling contaminated medical gas may include aspiration pneumonia.

According to the FDA, Air Liquide must also determine whether any other facilities of the company are in violation of cGMPs, provide the FDA with a list of such facilities and provide the agency with a certification that the company’s practices have ceased.

The FDA also noted that Air Liquide may resume filling its trailers and distributing medical gas once it has an expert consultant certify that its operations are in compliance.