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| The FDA issued Hospira a warning letter over how it manufactures the Plum A+ infusion pump.--Courtesy of Hospira |
Hospira ($HSP) 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.
In a letter dated May 9, the FDA details a litany of failures in design, corrective action, maintenance of records, document controls and adverse event reporting, all stemming from an inspection earlier this year. Most alarming, however, is that the agency is taking serious issue with the Plum A+, one of only three infusion devices Hospira doesn't aim to discontinue.
In the letter, the FDA chides Hospira for failing or refusing to report the results of adverse events, improperly handling customer complaints and mislabeling the Plum A+ pump's battery, among other problems.
Earlier this month, Hospira revealed its plans to change the way it does business in medical devices, retiring the Symbiq, GemStar and older Plum pumps--all of which have endured regulatory trouble. The company will replace them with the Plum A+, LifeCare PCA and Sapphire, which the company licensed from Q Core Medical back in January. The effort subtracted $181.5 million from profits last quarter and will shave 2% to 4% off of full-year sales, the company said.
Coupled with the strategic changes was a promise from Hospira to amend its quality systems to avoid future problems with the FDA. While the agency acknowledges Hospira's so-termed "Global Device Strategy," it still has serious reservations with the company's pump manufacturing.
The warning follows the FDA's February issue of a Form 483--notes that, as is the case here, often precede full-scale warning letters--and, as Hospira points out in a regulatory filing, the letter could lead to future delays of approval applications, seizure, injunction or financial penalty.
This latest letter follows one sent out in response to Hospira's pump manufacturing in Puerto Rico, and the FDA eventually decided to ban the company from importing Symbiq devices produced there, a bar yet to be lifted. If the ban stays in effect through the year, it could cut between $50 million and $100 million from annual sales, the company has said.
For now, Hospira plans to issue another response to the agency and do what it can to return to normalcy, the company said.
"The company takes this matter seriously and intends to respond fully in a timely manner to the warning letter," Hospira wrote in an 8-K. "The company does not expect that the warning letter will impact its 2013 financial guidance or the cost range associated with the company's recently announced device strategy."
- here's the warning letter
- read Hospira's 8-K
Editor's note: This story has been updated to include the LifeCare PCA infusion system, which will also be maintained by Hospira.