SAN DIEGO and HUNTERSVILLE, N.C., March 14, 2013 /PRNewswire/ -- Shareholder rights firm Robbins Arroyo LLP is investigating whether officers and directors of Impax Laboratories, Inc. (NASDAQ: IPXL) breached their fiduciary duties to shareholders by failing to correct the Company's inadequate quality controls and deficiencies in its manufacturing processes.
The FDA Notifies the Company of Its "Significant Violations of Current Good Manufacturing Practice Regulations"
On June 3, 2011, Impax received a warning letter from the Food and Drug Administration ("FDA") following an on-site inspection of Impax's Hayward, CA pharmaceutical manufacturing facility conducted between December 13, 2010 and January 21, 2011. In the warning letter, the FDA notified Impax of the company's "significant violations of Current Good Manufacturing Practice regulations for Finished Pharmaceuticals."Continued Manufacturing Deficiencies Persist at Impax's Hayward Facility Delay Bringing Rytary to Market On March 3, 2013, Impax announced the results of a subsequent FDA inspection of the Hayward Facility that included a re-inspection in connection with the May 2011 warning letter and a pre-approval inspection for the company's newly developed drug, Rytary. Following this inspection, the FDA issued a Form 483, "Notice of Inspectional Observances," documenting 12 problems, three of which were previously observed and noted in the 2011 warning letter. As a result of these continued manufacturing deficiencies, Impax has stated that it will be unable to bring Rytary to market before 2014. On this news, Impax's stock declined $5.20 per share, or 26%, to close at $14.80 per share on March 5, 2013. Robbins Arroyo LLP highlights that Impax shareholders have the option to pursue a shareholder derivative action through which shareholders aim to hold insider wrongdoers accountable for their actions, prevent future misconduct, and bring long-term value back to the company. Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003, DDonahue@robbinsarroyo.com, or via the shareholder information form on the firm's website. Robbins Arroyo LLP is a nationally recognized leader in securities litigation and shareholder rights law. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits, and has helped its clients realize more than $1 billion of value for themselves and the companies in which they have invested. For more information, please go to http://www.robbinsarroyo.com. Press release link: http://www.robbinsarroyo.com/shareholders-rights-blog/impax-laboratories-inc/ Attorney Advertising. Past results do not guarantee a similar outcome.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
24/7 market commentary from Jim Cramer and 20+ veteran Wall Street gurus. Get access to the latest trading ideas on stocks, options, and ETFs as well as a real-time forum to see the pros exchanging their investment ideas.
- Jim Cramer + 20 Wall Street pros
- Intraday commentary & news
- Real-time trading forum
- Actionable trade ideas
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV