Hospira Warned About Infusion Pump Problems

On August 23, Hospira Inc. received a warning letter from the U.S. Food and Drug Administration (FDA) over quality problems at the Costa Rican plant that makes most of its infusion pumps.

The warning, stemming from an April inspection by U.S. regulators, does not restrict production or product shipments from the plant in La Aurora de Heredia, Costa Rica, Hospira, according to a regulatory filing with the U.S. Securities and Exchange Commission. The FDA said Hospira’s initial response in May to the inspection was inadequate because the company has not made changes to correct problems, hasn’t created proper procedures for accepting products coming in, and is not keeping adequate records of the devices it makes.

Among the issues cited by the FDA were ongoing problems with the company’s Plum brand infusion pump, which Hospira recalled in February 2011 because of problems with its audible alarm. The company received complaints of alarm failures even after a supplier redesigned the part, the FDA said in the letter.

Hospira said it was still evaluating actions and associated costs to address the issues raised by the FDA.

“It seems FDA, with this warning letter, is not fully satisfied with their efforts to correct the alarm problems,” Morningstar analyst Michael Waterhouse said.

A Hospira spokeswoman said the company was switching alarm components for the pump, a process it expects to complete by early 2013.

The maker of medical devices and injectable specialty drugs has been working for several years to resolve manufacturing issues at some of its plants.

The Lake Forest, Ill.-based company was warned in 2010 about violations of Current Good Manufacturing Practice in two of its North Carolina facilities by the FDA. In this case, the company’s pharmaceutical production was under scrutiny. In April this year, FDA said that Hospira’s response to that warning was also insufficient.

Earlier this month, Hospira’s new Chief Executive Michael Ball told analysts the company was making progress addressing various manufacturing issues.

Hospira produces injectable drugs and infusion technologies.