Hospira Medical Device Facility Receives FDA Warning

Agency inspectors issued a warning after inspecting a medical device manufacturing facility in Costa Rica.

Hospira Inc. said Tuesday it received a warning letter from the Food and Drug Administration based on a recent inspection of a medical device manufacturing facility in Costa Rica.

The Lake Forest, Ill., company said it received the letter Thursday. The FDA said the facility was not complying with the agency's rules. The agency also 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.

The facility makes infusion pumps sold under the names Symbiq, Plum, Gemstar, and LifeCare PCA, and Hospira said most of its infusion devices and sets are manufactured at the Costa Rica plant. The FDA conducted its inspection in mid-April, and Hospira's initial response was made in early May.

The FDA noted that Hospira had to recall some of its Plum products in February 2011 because the audible alarms on the devices were not working properly, and even though Hospira made changes, customers reported similar problems with the alarms in early 2012.

The company said the warning letter does not restrict any production or shipping. Hospira said it is evaluating what to do to correct the matters the FDA raised in the letter and is determining what it will cost to resolve those issues. It said it will respond to the warning letter.

Hospira shares lost 45 cents to $33.36 Tuesday and added 45 cents to $33.81 in after-hours trading.

Source: Hospira via Associated Press

No votes yet