Apria Gets Another FDA Warning About Testing

Apria Healthcare Group Inc. has received another warning from federal regulators about infractions at one of its plants.

Apria’s facility in Lima, Ohio, failed to properly test certain batches of liquid oxygen before filling patient units, according to a warning letter last month from the Food and Drug Administration. The FDA also said the company failed to maintain adequate records.

Apria officials said the inspection at the Lima plant occurred before new FDA-approved policies were implemented and the FDA’s concerns were mostly record-keeping problems. The company, which provides medical services and equipment to patients at home, is confident the issues will be resolved, said Robert Holcombe, Apria’s vice president and general counsel.

“There was never any safety issue,” Holcombe said.

Apria has received two other warning letters from the FDA in the last year. One cited another Ohio facility in March, the other a facility in Las Cruces, N.M., in September.

The FDA sends hundreds of warning letters to companies each year, often for minor infractions of technical requirements, and only a small minority of them result in agency action.