USFDA import alert lifted from Costa Rica facility of Hospira
Hospira's Costa Rica facility received a warning letter from the agency in August 2012 as the devices manufactured at this site did not comply to the current Good Manufacturing Practices. Although no close out letter has been published but the ban has been lifted which seems to be a significant progress in Hospira's global device strategy initiated in 2013.
The lifting of ban will enable the facility to resume to sell products like Symbiq, Plum A+ and LifeCare PCA infusion pump to its US customers. Hospira is now hoping to launch a number of new IV devices including the SapphirePlus which is a device to improve the safety and efficacy of IV administration. Also an upgraded version of its Plum Infusion Platform will be available for an expanded range of drugs and feature wireless capability.
During an investor call in November management said that in 2015, Hospira would be focused on getting the remediation in the device strategy completed as the firm had to address the quality and compliance issues over the past few years. Hospira also received a warning letter in 2010 on its Rocky Mountain Facility in North Carolina and as a part of remediation efforts was operating at less than 70 % capacity in 2012. This facility was upgraded to VAI (Voluntary Action Indicated) by FDA in 2014 which means that the plant has returned to health.