Leiner Health Products, which is one of the biggest suppliers of OTC store-brand drugs and vitamins was accused of falsifying and manipulating test results at its Fort Mill, SC, manufacturing plant, according to an affidavit filed Friday with the U.S. District Court in Columbia, The Charlotte Observer reports.

The FDA also says Lenier should have immediately recalled several drugs during the past two years after the company’s own testing raised doubts about expiration dates, and the agency is investigating whether the Lenier committed criminal violations of the Food, Drug and Cosmetic Act, the affidavit states. You can see a list of Lenier products if you click here, and to read about North Castle Partners, which owns the company, look here.

Several tests conducted by Lenier since Aug. 3, 2005, showed several drugs didn’t meet FDA quality standards, according to the 29-page affidavit. The FDA searched the site Sept. 5 and seized documents, computer records and other evidence related to Leiner’s testing since Jan. 1, 2004. Leiner executives could not be reached for comment Saturday, the paper writes.

This is no small matter. Leiner supplies over-the-counter, store-brand drugs and vitamins to several of the nation’s biggest retailers, including Wal-Mart, Target, CVS, Walgreens and Costco. During a conference call with reporters and investors last week, Leiner ceo Bob Kaminski blamed employees who failed to follow company standards, and the responsible parties have been identified and “relieved of their duties.”

Apparently, the FDA investigation began in January after an employee notified the FDA of alleged violations. Following the initial complaint, 10 more complaints were received from several more employees who fingered upper management, the affidavit states. FDA inspections of the plant revealed “serious widespread violations within the laboratory and manufacturing divisions at the facility,” according to the affidavit.

The most serious alleged violations include:

• Manipulating and falsifying purity test results.
• Not obtaining data to support expiration dates.
• Not obtaining data supporting the quality and safety of the products.
• Not recalling drugs already on store shelves.
• Failing to document out-of-specification test results.

One employee told the FDA that Fort Mill Laboratory Quality Control Director Ramon Montes de Oca instructed laboratory personnel to “manipulate or falsify” lab test data that showed an allergy drug did not meet company standards for shelf life. Montes de Oca denied instructing analysts to obscure impurities when he met with investigators, the affidavit states. He could not be reached for comment, the paper writes.

But employees fault management. One lab analyst told investigators she was instructed by other analysts to ignore impurities and change test parameters to “see what they wanted to see,” the affidavit states. Another analyst told investigators that it was “just common knowledge” that impurities could be ignored, according to the affidavit.

The affidavit listed the results of 38 failed tests between August 2005 and Jan. 1, 2007, the paper writes. Of those, the FDA considered more than half to be “gross” out of specifications, the affidavit states. Among the drugs listed were an anti-inflammatory, a laxative and an antihistamine.

The affidavit also says that employees accused Leiner’s upper management of directing lab managers and analysts to change data to obtain desired results. Leiner’s upper management also was accused of pressuring managers and analysts to “use any means necessary to get the product released quickly,” according to the affidavit. Complaints further alleged that upper management received cash bonuses for achieving product release quotas.

Lenier has run afoul of federal laws before. In 2001, the company settled charges filed with the FTC of falsely labeling analgesics as being made in the US. In 2003, Lenier signed a deal to become an exclusive marketer of OTC products made by Dr. Reddy’s, the big Indian drugmaker. A year earlier, Lenier reportedly filed for Chapter 11 bankruptcy protection before emerging and being purchased by North Castle.