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FDA Warning for Costa Rica Hospira Infusion Pump Plant

FDA Warning for Costa Rica Hospira Infusion Pump Plant

August 30, 2012 — Hospira, Inc. announced that they received a warning letter from the U.S. Food and Drug Administration (FDA) dated August 22, 2012. In April, inspectors from the FDA cited quality problems at a Costa Rican plant that manufactures most of Hospira’s infusion pumps. Although the FDA has not yet posted the warning letter publicly, Hospira disclosed the letter in a mandatory regulatory filing with the Securities and Exchange Commission (SEC).

The plant is located in La Aurora de Heredia, Costa Rica. The warning letter did not place restrictions on the plant’s production or shipments of infusion devices. Analysts estimate that the Costa Rican facility accounted for 13.5% of the company’s 2011 sales, or about $550 million.

The FDA inspectors found that Hospira had not adequately addressed known problems with the alarms on some of its infusion pumps. Hospira’s Plum brand infusion pump was recalled in the U.S. in February 2011 due to a defective alarm. The manufacturer re-designed the alarm system and continued selling products, but Hospira has continued to receive complaints about defective alarms.

Officials for Hospira said that they will be switching components for the pump’s alarm system. They expect the new process to be complete by early 2013.

Hospira has been working to address ongoing quality problems at its facilities. In July 2012, the company recalled four different injectable cancer drugs because of glass particles embedded in the vials. Manufacturing problems at a plant in Rocky Mount, North Carolina led to a maintenance shutdown and shortages of several drugs. The FDA has also found problems at a facility in Boulder, Colorado. Many medications made by Hospira are on the FDA’s list of drug shortages.

Infusion pumps are external medical devices that mechanically deliver fluids, nutrients, and medications into a patient’s body. Doctors and patients rely on the products to deliver controlled amounts of fluids and medications. Unfortunately, problems with the devices can lead to drug overdoses, under-doses, and other therapeutic problems.

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