Injectable drugs maker Hospira Inc. (HSP) said Tuesday that the U.S. Food and Drug Administration completed an inspection of the company's Rocky Mount facility in North Carolina and issued a Form 483 with 20 observations, three of which were designated as repeat observations.
Lake Forest, Illinois-based Hospira, a provider of injectable drugs and infusion technologies, said it is taking the matter seriously. The company warned that any actions by the FDA or the company in response to the inspection could impact its ability to increase supply of products to the market, raise its costs for remediation activities and also adversely impact its operations.
Hospira has been under review by the FDA for quality concerns at its medical device unit, leading to maintenance shutdowns and shortage of drugs. The Rocky Mount facility has been subject to an FDA warning letter since April 2010.
The FDA completed the inspection of the Rocky Mount facility on March 1, 2013 and issued the Form 483, which is used by the FDA to document and communicate concerns discovered by the agency during its inspections. A recipient of Form 483 should respond to the FDA, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification of what the FDA requires.
Hospira noted that a number of the observations deal with matters for which remediation was already underway but not yet complete or are matters previously self-identified for remediation by the company. Hospira said it will seek input from the FDA regarding the scope and timing of remediation efforts at the facility.
Further, Hospira said it will evaluate whether there will be any financial impact from this matter and will include any such impact in its 2013 earnings guidance that will be announced as part of its first-quarter 2013 earnings call.
In February, the FDA expanded an import ban on several of Hospira's products made in a Costa Rica plant. The agency had earlier issued an import ban on the company's Symbiq intravenous pump in November 2012.
Following the FDA ban, Hospira withdrew its financial outlook for fiscal 2013 that was provided by the company on February 13 along with the announcement of its financial results for the fourth quarter.
HSP closed Monday's trading at $29.77, up $0.32 on a volume of 1.79 million shares.
by RTT Staff Writer
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