FDA Warning Letter Targets Apria Oxygen
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Apria Healthcare Group Inc., one of the largest providers of home health care services, failed to adequately document and test procedures to ensure the quality of its medical oxygen, the U.S. Food and Drug Administration said in a warning letter.
The FDA’s Feb. 10 letter cited the Costa Mesa-based company’s facility in Des Moines, Iowa. During a visit in January, FDA inspectors found that the facility hadn’t kept proper records documenting quality and purity testing of its oxygen and didn’t ensure that its test procedures met necessary standards, the FDA said.
Apria officials weren’t available for comment. The company’s shares rose 13 cents to $8.06.
The company received seven warning letters in 1997.
The FDA sends hundreds of warning letters to companies each year, and only a minority of them result in significant agency action. Still, the letters can be the last notice before the FDA takes steps such as holding up product shipments and pursuing civil fines.
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