August 30, 2012 — The drug and medical device company Hospira Inc. announced in a regulatory filing that the U.S. Food and Drug Administration (FDA) sent a warning letter. FDA inspectors found problems at a Costa Rican facility that manufactures most Hospira infusion pumps. The letter was dated August 22, 2012, and has not yet been posted publicly on the FDA website. Hospira disclosed the warning letter in a filing with the Securities and Exchange Commission (SEC), as is required by law.
The problems cited in the letter stem from an inspection the FDA performed in April 2012. The inspectors were concerned that Hospira failed to adequately address known safety concerns with the alarms on most of its infusion pumps. The Plum brand of infusion pump was recalled in February 2011 due to complaints about a faulty alarm. Hospira re-designed the alarm system and continued selling the products. However, the company continued receiving complaints. The FDA was concerned that Hospira did not address these complaints adequately.
In response, Hospira officials said that they have re-designed the alarm system again, and infusion pumps will have the new system by early 2013.
The Costa Rican facility is located in the city of La Aurora de Heredia. The FDA warning letter did not place any restrictions on production or shipments from the facility, so supplies of the infusion pumps and other products should not be disrupted. Analysts estimate that the facility accounted for 13.5% of sales in 2011, or about $550 million.
Hospira executives say they are in the process of correcting known safety and quality issues with their products. In July 2012, four types of cancer drugs were recalled after inspectors found glass particles embedded in the neck of the product vials. The company was also forced to temporarily shut down a facility in Rocky Mount, North Carolina after inspectors found manufacturing problems. Inspectors have also found problems at a Hospira plant in Boulder, Colorado. The shutdowns have stopped the production of several drugs, which are now on the FDA’s drug shortage list.
Infusion pumps are medical devices that administer liquids to a patient — including blood, nutrients, and medications including painkillers, cancer drugs, and more. Physicians and their patients rely on these machines to accurately deliver the correct amount of fluid. When there are problems with these devices, they can cause overdoses, under-doses, and other life-threatening medical problems.
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