The law firm Finkelstein Thompson LLP is investigating potential claims on behalf of shareholders of the drug manufacturer Impax Laboratories, Inc. (“IMPAX” or the “Company”) (NASDAQ: IPXL). If you are interested in discussing your rights as an Impax shareholder, or have information relating to this investigation, please contact Finkelstein Thompson's Washington, DC offices at (877) 337-1050 or by email at firstname.lastname@example.org.
The investigation focuses on potential liability arising from Impax’s management of its Hayward, California manufacturing plant. On March 4, 2013, the Company disclosed that the FDA had completed a re-inspection of the plant, and issued a Form 483 setting forth twelve concerns, or “observations,” that the FDA has regarding manufacturing practices at the plant. The FDA reportedly designated three of the observations as repeat observations, as it noted them in a prior inspection of the plant in March 2012. The Company further disclosed that until the FDA confirms that the plant is in compliance with applicable manufacturing standards, “approval of pending and new applications listing the Hayward facility as a manufacturing location of finished dosage forms may be withheld.”
The new Form 483 is the latest episode in a course of events that began in 2011, with the FDA’s issuance of a Warning Letter to the Company regarding the Hayward plant. The Warning Letter stated that FDA investigators had identified “significant violations of Current Good Manufacturing Practice” at the plant, resulting in the manufacture of adulterated drugs.
Shares of Impax closed down 26% percent on the day following the Company’s announcement.Finkelstein Thompson LLP has spent over three decades delivering outstanding representation to institutional and individual clients in financial litigation, and has been appointed as lead or co-lead counsel in dozens of shareholder class actions. Indeed, the firm has served in leadership roles in cases that have recovered over $1 billion for investors and consumers.