Correction – this article mistakenly suggested that the manufacturing facility in question produces infusion pumps.
Medical device company Hospira (NYSE:HSP) disclosed an FDA inspection of its Rocky Mount, N.C., facility, saying 5 agency inspectors reviewed the facility for 3 weeks and issued a Form 483 warning flagging 20 problems at the plant.
Hospira will now respond to the 20 observations with a remediation and modernization plan, according to a press release.
The Lake Forest, Ill.-based company’s primary products are injectable drugs and infusion devices. According to the statement, Hospira "takes this matter seriously" and is working closely with FDA inspectors to respond to the findings.
The device maker is trying to soften the blow by working with the federal watchdog agency to keep remediation costs down and ensure critical drugs remain on the market.*
Hospira said it plans to include the impacts of the inspection in its updated 2013 guidance as part of its 1st-quarter earnings release. That would be the 2nd revision to Hospira’s 2013 guidance since the FDA banned 3 infusion pumps shortly after its 2012 results were reported in February.
Hospira lowered its 2013 forecast after the FDA banned infusion pump imports from a facility in Costa Rica, which is the subject of a different FDA warning letter also issued over infusion pump problems.