FDA Cites Apria for Oxygen-Handling Problems

The U.S. Food and Drug Administration cited Apria Healthcare Group Inc. once again for improper procedures in filling patients’ oxygen canisters with liquid gas from a supply tank.

On Sept. 4, federal inspectors found improperly calibrated equipment, insufficient record keeping and inadequate supervision at the home health care company’s branch in Harriman, Tenn., according to a warning letter that the agency made public Tuesday.

The citation was the fifth in less than two years that Apria has received regarding improper processing of liquid oxygen at one of its branches.

“We take any warning letter very seriously and we work diligently to correct any concerns the FDA has,” Apria spokeswoman Sheree Aronson said.

She noted, however, that federal inspections have turned up relatively few problems for a company of this size. Apria operates more than 300 branches nationwide, and regulators inspected 50 sites in the last three months.

“Apria has never been cited for anything that created a patient-safety issue,” Aronson said.

Ira Loss, an analyst who follows regulatory issues, said the agency’s repeated notices to Apria are “a bit disconcerting. There seems to be a pattern here.”

But Loss did not find such a problem surprising in a company in organizational “disarray” over poor financial results and executive turnover. The company also is seeking a buyer.

He said the FDA probably would not take more serious actions unless the company ignores the recent warning.

“The warnings are concerning different locations--and that’s an advantage for Apria,” he said.

Agency officials could not be reached for comment.

Last year, Apria’s branch in Las Cruces, N.M., was cited for failing to test each shipment of medical oxygen before filling canisters. Inspectors also said employees had received insufficient training, and record keeping was inadequate. A plant in Louisville, Colo., had similar violations.

This year, branches in Lima, Ohio, and Sacramento also were cited for insufficient testing. Sacramento inspectors also found that the company failed to comply with labeling regulations.