Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

RELATED NEWS
Trade HSP now with 
3/5/2013 8:00 AM ET

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

Quick Facts

Editors Pick
Stocks continue to show a lack of direction in mid-day trading on Thursday, extending the lackluster performance seen earlier in the session. The major averages have spent the day bouncing back and forth across the unchanged line. After speaking with President Barack Obama by phone about stalled immigration reform legislation on Wednesday, House Majority Leader Eric Cantor, R-Virg., claimed the president still does not understand how to work with the Republican-controlled House. Growth in Philadelphia-area manufacturing activity has accelerated by much more than anticipated in the month of April, according to the results of the Federal Reserve Bank of Philadelphia's Business Outlook Survey released on Thursday. The Philly Fed said its diffusion index of current activity climbed to 16.6 in April from 9.0 in March, with a positive reading indicating growth.
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.