Hospira has received a Form 483 from the US Food and Drug Administration (FDA) noting three observations at its Kansas manufacturing facility.
In last week’s conference call to discuss Q3 earnings, there was strong focus on the status of the company’s Rocky Mount plant in North Carolina following several years of turbulence on the back of a 2010 FDA warning letter.
However, whilst CEO Michael Ball told stakeholders while Rocky Mount could be mostly remediated by the end of 2013, he also informed stakeholders the firm’s McPherson, Kansas plant received a 483 during the period.
This was confirmed to Outsourcing-Pharma.com by spokesman Dan Rosenberg who said: “The Agency inspected our facility in McPherson, Kansas, during the third quarter, which resulted in three observations.”
He added: “We have responded to the FDA with our action plan to address those observations.”
The facility manufactures injectable generics and was subject to a $60m expansion back in 2006 .
This latest 483 – an action highlighting observations following an FDA inspection which may or may not result in a Warning Letter – comes in a long line for Hospira.
As well as Rocky Mount, an API facility in Boulder, Colorado was inspected in Q2 and two observations were noted by the FDA. As for the firm’s Irungattukottai (IKKT) site in India, it received a Warning Letter in the same quarter .
The company’s device manufacturing business too has also seen a number of regulatory ticking offs of late, with the Lake Forest, Illinois site’s Warning Letter in May this year and issues at a Costa Rican facility leaving the firm in a tight predicament earlier this year.
Hospira spoke last quarter about the threat of suspension of ISO certification following an audit by the National Standards Authority of Ireland (NSAI) that noted three major non-conformities.
However, such fears were put to rest this quarter, with another audit at Lake Forest and Costa Rica in mid-October resulting in a formal notification the NSAI would renew the ISO certifications for the plants.
Hospira’s device business is not yet out the water, however, as a US import ban means “device products remain on ship-hold in all major markets,” according to Ball.
“Lifting the import ban in the U.S. will require, at a minimum, that the FDA reinspect both our Costa Rica plant and our Lake Forest site and that the FDA acknowledges sufficient progress with our device strategy,” he said last week. “The timing of these events remains uncertain at this point.”