FDA Cites Apria for Third Time in a Year

COSTA MESA — Federal regulators cited Apria Healthcare Group Inc. for failing to follow proper procedures in manufacturing oxygen products at its Sacramento plant.

In a warning letter issued May 21, the Food and Drug Administration called samples of the home health-care company’s oxygen product “adulterated” because Apria failed to properly test the concentration of liquid oxygen in products used by home-based patients. The FDA disclosed the letter Tuesday.

The agency also faulted the Costa Mesa-based company for insufficiently monitoring its own record keeping and for not complying with regulations on labeling products.

The warning is the third such notice in less than a year that the FDA has issued to Apria for insufficient testing of liquid oxygen.

In February, the agency issued a warning regarding testing of liquid oxygen at Apria’s facility in Lima, Ohio.

Last September, the agency faulted the company’s facility in Las Cruces, N.M., for failing to test oxygen shipments, keep records or adequately train employees. The agency also noted at the time that Apria’s facility in Louisville, Colo., had been cited for similar violations earlier last year.

In the September warning letter, the agency noted that “these repetitive deviations may be indicative of corporation-wide noncompliance.”

An Apria spokeswoman said the company is working to correct problems in Sacramento and throughout the company.

She said she didn’t know whether the FDA had specifically targeted the company for widespread inspection of its manufacturing of oxygen products. She said, however, that it’s not surprising that Apria would receive a few warnings. The company is the largest in the industry, with more than 300 facilities that handle oxygen products.

She said the company is working with the agency to overhaul its systems for regulatory compliance.