Hospira is back in the FDA's spotlight as the agency issued another warning letter over problems in the company's infusion pump manufacturing, this time targeting the device Hospira hopes to carry it back to revenue growth.
Injectable drugmaker Hospira has a lot to juggle just now. It has big problems facing its infusion pump business but that doesn't mean issues in drug manufacturing have been resolved. It continues to issue product recalls. And it is feeling the need to ramp up production in the face of shortages of some of its products even as it is trying to upgrade its key drug manufacturing plant in the face of FDA concerns.
After a year of recalls, bans and technical failures, Hospira is changing the way it does business in medical devices, planning to discontinue some of its infusion pumps and focus on next-generation technology.
It has been a particularly bad few days for Hospira, with both the company and the FDA alerting healthcare providers of problems with multiple lots of its drugs. That was in addition to an alert for one of its medical products.
Hospira is warning customers of a dangerous battery malfunction with its GemStar infusion system, and the FDA has assigned its most serious label to the problem, warning that a resultant delay in delivery could cause serious injury or death.
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For the last several years the business model for Hikma's injectable drug business has gone something like this: Market leader Hospira reports a problem and Hikma picks up more business.
Baxter International has picked up the former Genmab antibody plant near Minneapolis for a small sum and will now invest about $300 million to get it ready for its own use.
Hospira last year brought in John B. Elliot, "a seasoned global leader," to help get its manufacturing mess sorted out and get the company back in the good graces of the FDA. Almost exactly a year later, Elliot is out and the injectable drugmaker has tagged another of its new manufacturing execs to get the job done.
It's at least the fourth time this year that Hospira has recalled a drug.