FDA blocks Hospira from importing pumps
Hospira ($HSP) is facing another headache over its Symbiq infusion pumps, as the FDA is prohibiting the company from importing the devices into the U.S.
Hospira disclosed the import alert in a regulatory filing but didn't specify what prompted the FDA's action. If you're looking for a possible reason, though, you can pick from among the company's recent woes.
Last month, the FDA slapped its most serious label on a recall of the some of the devices, warning that a touch screen malfunction could put patients in danger. Before that, the FDA issued a warning letter to the company over manufacturing practices at the Costa Rica plant that makes Symbiq and other infusion pumps.
Hospira found out about the FDA's prohibition on Nov. 8, one day after it placed a voluntary hold on shipping Symbiq units to new U.S. customers. The agency's action affects only Symbiq units, leaving its drugs and other devices cleared for U.S. sale.
The company says the import ban won't tarnish 2012 earnings, but Hospira sounded a notably wary tone about its ongoing effort to appease the FDA.
"There can be no assurance that the FDA will be satisfied with the company's responses or that the company will not be subject to additional further regulatory action by the FDA," Hospira wrote in an 8-K. "Any such further actions could significantly disrupt our ongoing business and operations and have a material adverse impact on our financial position and operating result."
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