FDA Flags New Concerns regarding Violation of Injectable-Drugs by Hospira Inc.

Hospira Inc. released reports that U.S. health regulators issued a letter raising new concerns about one of the injectable-drugs maker's largest manufacturing plants in Rocky Mount, N.C. This sent the company's shares down by four percent, according to The Chicago Tribune.

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

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

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, Hospira said in a regulatory filing.

"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.

The FDA has expressed similar concerns regarding the manufacturing practices at Hospira's other plant in Clayton and La Aurora de Heredia, Costa Rica, leading to maintenance shutdowns and drug shortages.

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

Hospira's shares were down 4 percent at $28.55 before the bell on Tuesday, according to Reuters. They closed at $29.77 on the New York Stock Exchange on Monday.