Operations will cease by the end of June 2015 at the Clayton, North Carolina facility, Hospira announced last week, following an internal review of manufacturing capabilities and market needs which found the plant to be uncompetitive in the long run.
“The closure decision is a result of extensive analysis of the plant, careful assessment of market needs for the products manufactured there, and available capacity within our operations network,” Hospira spokesperson Shannon Wong told in-Pharmatechnologist.com.
“The investments required to continue our modernization efforts at the site, a plant limited in size and scale, also contributed to the closure decision. As a result of these factors, Hospira determined that it is not cost effective - over the long term - to continue manufacturing at Clayton.”
The site manufacture four products which will either be outsourced, discontinued or transferred to other Hospira sites, but as a matter of course Wong was only able to confirm that the short-acting, intravenously administered amnestic drug Propofol was made there.
In addressing compliance issues, a shutdown was facilitated in 2012 which led to a temporary shortage of Propofol.
Regulatory Issues
Clayton is one of several Hospira facilities which have been hit with regulatory action over the past few years, and a warning letter from the US Food and Drug Administration (FDA) in April 2010 revealed along with Propofol, Liposyn, and Cleviprex emulsion products were being produced at the site.
While the plant has not received a close-out letter, a 2013 inspection found no observations and Wong told us “the site is GMP and FDA compliant, and we are confident in the high-quality products manufactured there.”
She added Hospira has invested more than $1bn across its manufacturing network – including over $200m in remediation efforts at the nearby beleaguered Rocky Mount plant – to enhance current operations and increase manufacturing capacity, but did not break-down how much has been pumped into Clayton specifically.
Across the two sites in North Carolina, Hospira employs almost 3,000 people. The decision to shut Clayton will affect 250 jobs.