Investigation Overview
March 5, 2013 (Update) -- On March 04, 2013, Impax Laboratories, Inc. (NASDAQ: IPXL) announced that the U.S. Food and Drug Administration (FDA) completed its re-inspection of the Companys Hayward manufacturing facility in connection with the previously disclosed Form 483 issued in March 2012.
Impax Laboratories Inc said that at the conclusion of this inspection, the FDA issued a new Form 483 with twelve (12) observations, three (3) of which are designated as repeat observations from inspections that occurred prior to the Warning Letter.
Shares of Impax Laboratories Inc (NASDAQ:IPXL) dropped from $20.00 on March 4, 2013, to as low as $14.49 per share on March 5, 2013.
June 12, 2011 (Shareholders Foundation) -- Following the announcement that Impax Laboratories received a warning letter from the FDA an investigation on behalf of investors of Impax Laboratories Inc (NASDAQ:IPXL) concerning possible violations of Federal Securities Laws was announced.
The investigation by a law firm focuses on whether Impax Laboratories Inc or others have violated federal securities laws by issuing false and misleading statements to its shareholders and/or whether certain officers and directors at Impax Laboratories Inc. breached their fiduciary duties to sharesholders.
Impax Laboratories annual Revenue more than quintupled from $166.06million in 2007 to $879.51million in 2010. Its Net Income almost doubled from $125.41million in 2007 to $250.42million in 2010. However for the first quarter in 2011 Impax Laboratories Inc reported a substantially lower quarterly Revenue of $108.65million compared to $323.33million one year earlier. Its quarterly Net Income was only almost 10% o its quarterly Net Income a year earlier. Impax Laboratoriess first quarter Net Income in 2011 was $13.86million compared to $131.49million in 2010.
Shares of Impax Laboratories Inc (Public, NASDAQ:IPXL) rose from roughly $5 per share in March 09 to as high as high as $27.85 per IPXL share on May 9, 2011.
Then on June 6, 2011 Impax Laboratories announced that late Friday, June 3, it received a warning letter from the U.S. Food and Drug Administration (FDA) dated May 31, 2011 related to an on-site inspection of its Hayward, Calif. manufacturing facility conducted between December 13, 2010 and January 21, 2011. A media report from June 6 said that during a review, FDA inspectors found problems in Impax Laboratories sampling and testing, its production record review, and the process it used to determine why manufacturing batches did not meet quality specifications. Based on the inspection results, Impax Laboratories said it recalled five production lots of the cholesterol drug fenofibrate in March.
NASDAQ: IPXL stock fell from as high as $27.85 in May to $20.34 on June 8, 2011.