By Chris Anderson
COATESVILLE, PA -Inspections by The U.S. FDA in early April shut down Air Liquide America Corp.'s (ALAC) medical gas facility here for failing to comply with certain current Good Manufacturing Practices (cGMPs) in the use of its industrial-grade trailers. Specifically, on three separate inspections, the FDA found that Air Liquide failed to assure that its trailers used for the transport of medical products 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, in a press release announcing the action. "Practices that may endanger the public health cannot be tolerated."
Officials at Air Liquide note that none of its customers served from the Coatesville facility experienced any interruption of service and that the action at Coatesville was more the result of an administrative snafu than of the company cutting corners in its distribution of medical gasses. ALAC's Coatesville facility does not dispense gas products for the medical industry. Instead, trucks running from that location buy gas from a competitor for delivery to its customers in the area, according to Walter Mason, Ph.D., vice president of quality and regulatory affairs for Houston-based ALAC.
"We provide the same service for competitors at many of our other medical gas facilities and our procedure is to purge trucks prior to filling, when necessary," says Mason. "Some of the locations where we purchase medical products do, in fact, purge our trailers when necessary. Unfortunately, this location did not follow that practice."
As part of the FDA action, Air Liquide's Fairfield, AL, medical gas distribution operations were also shut down as it also used an outside source as a supplier. To come into FDA compliance, ALAC has earmarked specific trailers at both facilities to deliver only medical gases. It has also conducted an internal survey of its 17 other medical gas facilities across the country and reported its findings to the FDA. The Coatesville and Fairfield operations were the only ones affected by the action, as these were the only facilities using an outside supplier for medical gases.
At press time, ALAC had submitted the name of a third-party inspector to the FDA who would certify that Air Liquide's operations were in compliance. Once the inspection was completed and accepted by the FDA, Air Liquide could resume operation at both locations. "We anticipate that we will be up and running by the end of July," says Mason.