Infusion pump maker Hospira (NYSE:HSP) received an FDA warning after the federal watchdog agency recorded manufacturing violations at the company’s Costa Rica manufacturing facility.
In September 2011 Hospira recalled certain Plum infusion pumps after receiving reports that the devices’ alarms were not functioning.
The device maker corrected the problem and redesigned certain components of the pumps, but in March 2012 Hospira received "multiple complaints" nothing the same issue, according to the FDA warning.
The FDA cited Hospira for a "failure to identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems" as well as a "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 any any shipment or production restrictions at the facility, and that the company is evaluating what actions to take to address the FDA’s concerns.