FDA warns medical device company to comply with its rules

Infusion pump 435x565 FDA warns medical device company to comply with its rulesThe Food and Drug Administration (FDA) warned Hospira Inc. that its medical device manufacturing facility in Costa Rica was not complying with the agency’s rules.

The facility makes infusion pumps sold under the names Symbiq, Plum, Gemstar, and LifeCare PCA. The FDA conducted an inspection in mid-April, and Hospira’s initial response was made in early May. Hospira had to recall some of its Plum products in February 2011 because of a defect that prevented the audible alarms of the devices from working properly. Hospira claimed to have made changes, but customers reported similar problems with the alarms in early 2012.

The FDA said Hospira’s initial response to the inspection “was inadequate because the company has not made changes to correct problems, hasn’t created proper procedures for accepting products coming in, and is not keeping adequate records of the devices it makes,” according to PharmPro.

Hospira says the warning letter does not restrict production or shipping of products from the facility. Hospira also said it is evaluating what to do to correct the problems cited by the FDA and determining the cost to resolve the issues. Hospira is expected to respond to the FDA warning letter soon.

Source: PharmPro