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US FDA issues warning to medical device maker over Costa Rican facilities

August 29, 2012

Infusion pump maker Hospira received an FDA warning after the federal agency found manufacturing violations at the company’s Costa Rica facility located in the province of Heredia, north of the capital.

In September 2011, Hospira recalled certain Plum infusion pumps after receiving reports that the devices’ alarms were not functioning.

The company corrected the problem and redesigned certain components of the pumps, but in March, Hospira received “multiple complaints” on the same issue, according to the FDA warning.

After an inspection in April this year, the FDA cited Hospira for “failure to identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems” as well as “failure to implement and record changes in methods and procedures needed to correct and prevent identified quality problems.”

Hospira noted that the warning did not result in any shipment or production restrictions at the facility, and the company is evaluating what actions to take to address the warning.

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