FDA flags new concerns on Hospira’s Rocky Mount plant

FDA flags new concerns on Hospira’s Rocky Mount plant

March 6th, 2013 // 1:32 pm @

Hospira Inc said U.S. health regulators raised fresh concerns about the injectable-drugs maker’s troubled Rocky Mount, North Carolina manufacturing plant – one of its largest production facilities.

The much-awaited outcome of the FDA re-inspection of the plant did not provide significant additional clarity for the stock, Morgan Stanley analyst Marshall Urist wrote in a note.

“This outcome appears to fall somewhere in the middle between clearly positive and a material setback.”

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Hospira’s Rocky Mount facility has been under the FDA scanner since April 2010, when the regulator issued a warning letter stating manufacturing practices at the plant violated its defined standard practices.

The company said on Tuesday that the FDA inspected the facility and issued a letter outlining 20 concerns, three of which the agency had expressed earlier.

RBC Capital Markets analyst Shibani Malhotra said the repeat observations were bad news as it meant Hospira was unable to address concerns initially raised by the FDA.

Hospira said in a regulatory filing that a number of these concerns were based on issues that are currently being resolved or have been identified by the company previously and would be addressed.

“Any actions by the FDA or the company in response to this inspection could impact the company’s ability to increase supply of products to the market,” the Illinois-based company said.

However, analyst Malhotra said the FDA would probably allow the company to continue manufacturing the drugs it supplies exclusively and those that are in short supply, unless there was a safety issue.

The FDA has expressed similar concerns about manufacturing practices at Hospira’s other plants in Clayton, North Carolina and La Aurora de Heredia, Costa Rica, leading to maintenance shutdowns and drug shortages.

The company withdrew its 2013 profit and revenue forecast last month after quality issues at its plants prompted the FDA to impose an import ban on some of its products.

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