Apria Plant Gets Another Warning
COSTA MESA — Apria Healthcare Inc.’s liquid oxygen plant in Rochester, N.Y., is in “serious violation†of federal law, the U.S. Food and Drug Administration said in the seventh warning letter sent to the company this year.
The medical oxygen processed at the facility is considered adulterated because Apria workers don’t correctly test the bulk liquid oxygen it buys for strength and other qualities before shipping it out for use in patients’ homes, the FDA said. The company also doesn’t compare samples of label shipments to a master label before accepting or rejecting them, the agency said.
The Costa Mesa-based provider of home health-care products and services said it was aware of the letter and had already responded to the FDA.
“We have redoubled our training efforts to ensure compliance with FDA regulations and Apria’s own policy,†spokeswoman Sheree Aronson said.
Overall, the company’s facilities were inspected by the FDA 183 times during the year, generating warning letters less than 5% of the time, Aronson said.
“We’re working to the point where we receive no warning letters,†she said. “But in light of the total number of inspections, we’re generally satisfied.â€
Apria and the FDA revamped and improved the company’s FDA compliance program in the fourth quarter of 1996, and the agency increased its inspection levels as a result, Aronson said.
While the number of warning letters overall increased in 1997 compared to 1996, they decreased as a percentage of each inspection, she said.
The FDA sends hundreds of warning letters to companies each year, and only a few result in significant agency action.
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