FDA Warns Hospira, Inc. Over Costa Rica Infusion Device Plant
Published: Aug 29, 2012
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 Rice. 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.