Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

FDA Issues Form 483 With 20 Observations On Hospira's Rocky Mount Facility

RELATED NEWS
Trade HSP now with 

The U.S. Food and Drug Administration or FDA, on March 1, 2013, completed an inspection of Hospira, Inc.'s (HSP: Quote) facility in Rocky Mount, North Carolina, which was conducted by five inspectors over a three-week period. The company said it is making this disclosure because this facility has been subject to an FDA warning letter since April 2010. At the close of the inspection, the FDA issued a Form 483 with 20 observations, three of which were designated as repeat observations.

The pharmaceutical and medication delivery company would be seeking input from the FDA on the scope and timing of remediation efforts at the facility. For the past few years, the company along with FDA has been working to balance remediation efforts with the production of market critical drugs and would be dialoguing with the FDA as to whether this balance remains appropriate.

While the company is taking this matter seriously, any actions by it or the FDA with respect to this inspection could impact its ability to increase supply of products to the market, could impact its costs for remediation activities or have other adverse impacts on the company's operations.

In addition, Hospira is yet to evaluate whether there would be any financial impact from this matter, and if any would be included as part of its earlier announced intention to issue 2013 guidance as part of its first quarter 2013 earnings call.

Register
To receive FREE breaking news email alerts for Hospira Inc and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
LinkedIn Corp., the world's largest online professional network, said Thursday after the markets closed that it swung to a second quarter loss, hurt by higher costs and expenses even as revenue surged 47%. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue. Kraton Performance Polymers, Inc. (KRA), Wednesday reported second-quarter net income of $11.1 million or $0.33 per share, up from $3.8 million or $0.12 per share last year. Adjusted earnings improved to $0.46 per share from $0.15 per share last year. Revenues for the quarter dropped to $323.8... Organic grocer Whole Foods Market, Inc. said Wednesday after the markets closed that its third quarter profit rose 6.3% from last year, as same-store sales increased 3.9%. The company's quarterly earnings per share also came in above analysts' expectations, but its quarterly sales fell shy of analyst' forecast.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.