Investigation Overview
November 18, 2014 (Shareholders Foundation) - An investigation on behalf of investors, who currently hold shares of Impax Laboratories Inc (NASDAQ:IPXL), was announced over potential breaches of fiduciary duties by certain Impax Laboratories officers and directors.
The investigation by a law firm concerns whether certain Impax Laboratories Inc (NASDAQ:IPXL officers and directors breached their fiduciary duties and caused damage to the company and its shareholders.
Recently a lawsuit was filed against Impax Laboratories Inc over alleged violations of Federal Securities laws. The plaintiff alleges that Defendants made certain allegedly false and/or misleading statements and/or failed to disclose that Impax Laboratories Inc failed to maintain proper quality control and manufacturing practices at its Taiwan facility in violation of current Good Manufacturing Practices ('cGMP'), that the manufacturing deficiencies at the Taiwan facility could have a material adverse impact on Impax Laboratories Incs ability to successfully launch its new drug, RYTARY, that the manufacturing deficiencies at the Taiwan facility jeopardized Impax Laboratories Incs ability to manufacture, sell, and distribute generic pharmaceutical products, and that based upon the above, Defendants lacked a reasonable basis for their positive statements about Impax Laboratories Inc and its outlook, including statements about its ability to launch RYTARY.
On July 29, 2014 Impax Laboratories, Inc.announced that the U.S. Food and Drug Administration (FDA) performed a general GMP inspection and a Pre-Approval Inspection for RYTARYTM at the Company's Taiwan manufacturing facility from July 21 to July 26, 2014 and that at the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations.