FDA SUSPENDS OPERATIONS OF MEDICAL GAS FACILITY

The FDA has shut down certain operations of Air Liquide America Corp. (ALAC), a medical gas facility in Coatesville, Penna. The company had failed to assure that its industrial-grade trailers (also used for storing and hauling medical gases) are clean, purged, and completely free of contaminants prior to having them filled with medical gas, thereby creating a potential hazard for patients who use the product

"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."

ALAC had agreed to comply with FDA product safety regulations called Current Good Manufacturing Practices (CGMP) in a consent decree (a court-sanctioned agreement between two parties) signed in November, 1997, but an FDA inspection on April 2, 3, and 10, 2002, found that the Coatesville facility had failed to meet the agreed upon standards. As a result, the inspected plant must immediately stop having their trailers filled with medical gas and must stop distributing medical gases.

Of greatest concern is that the use of trailers that have not been determined to be free of industrial gas could result in a contaminated medical gas. The consequences of inhaling contaminated medical gas may include aspiration pneumonia.

ALAC 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 to FDA a certification that the violative practices have ceased.

ALAC may resume having its trailers filled with medical gas and distributing it to its medical customers once it has an expert consultant certify to FDA that its operations are in compliance with CGMP.

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