Large medical gas provider violated a court order to correct safety violations. The Food and Drug Administration has shut down certain operations of a large medical gas provider, saying it violated a court order to correct safety violations.
At issue is the Coatesville, Pa., branch of Air Liquide America Corp.
The FDA said that facility hauled different types of gases — industrial and medical — in the same trailers, and failed to follow FDA rules to ensure the trucks were properly cleaned between hauls.
Following those rules is crucial to ensure that medical oxygen isn’t dangerously contaminated, the FDA said.
French-owned Air Liquide signed a consent decree in late 1997 outlining the standards it must follow, but an FDA inspection of the Coatesville facility in April uncovered violations of that court-ordered agreement.
company may resume filling its trailers with oxygen at the facility once an expert consultant certifies
The company may resume filling its trailers with oxygen at the facility once an expert consultant certifies that Air Liquide is following the rules, the FDA said.
“We met with the FDA last Friday and believe we have all outstanding issues resolved,” a spokeswoman from Air Liquide’s U.S. headquarters in Houston said Wednesday.