FORT MILL -- Federal investigators believe Leiner Health Products falsified and manipulated test results at its Fort Mill drug manufacturing facility, according to an affidavit filed Friday with the U.S. District Court in Columbia.
The federal Food and Drug Administration also says the company should have immediately recalled several drugs during the past two years after the company's testing raised doubts about the drugs' expiration dates, according to the affidavit, signed by an FDA special agent.
The FDA is investigating whether the Carson, Calif.-based drug and vitamin company committed criminal violations of the Food, Drug and Cosmetic Act, the affidavit states. Leiner supplies over-the-counter, store-brand drugs and vitamins to national retailers, including Wal-Mart, Target, CVS, Walgreens and Costco.
Federal law- requires drug companies to test sample lots of its products for quality and shelf-life, the affidavit states. But records gathered by the FDA show that several tests conducted by the company since Aug. 3, 2005, revealed several drugs did not meet standards.
Investigators believe Leiner manipulated some tests, according to the affidavit. The 29-page affidavit states such violations can compromise the safety and effectiveness of the drugs.
The affidavit and a search warrant for the facility in Lakemont Business Park off Carowinds Boulevard state U.S. Food and Drug Administration officials searched the site Sept. 5 and seized multiple documents, computer records and other evidence related to Leiner's testing of its over-the-counter products since Jan. 1, 2004.
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