Leiner Health Products, a drug maker that produces store brand over-the-counter medications and vitamins for retailers like Wal-Mart, Target, CVS and others, has been accused by the Food & Drug Administration (FDA) of falsifying and manipulating test results on its products. The accusations led the FDA to raid the company’s Fort Mill, South Carolina manufacturing facility earlier this month. The FDA is investigating the California-based company to see if it committed criminal violations of the Food, Drug and Cosmetic Act.
The FDA raided Leiner’s Fort Mill factory on September 5. The raid was the culmination of an investigation that the FDA had begun in January after employees at Fort Mill notified the agency of violations at the plant. The FDA said its subsequent inspections revealed serious violations that substantiated most of the employees’ claims. Those violations included manipulating and falsifying purity test results; not obtaining data to support expiration dates; not obtaining data supporting the quality and safety of products; not recalling defective drugs already on store shelves; and failing to document out-of-specification test results.
According to an affidavit filed in the US District Court in Columbia, South Carolina on Friday, records gathered by the FDA showed that several test conducted by Leiner since August 3 on medications produced at the Fort Mill factory revealed that some products did not meet standards. The affidavit also accuses Leiner of falsifying testing records, and lists the results of 38 failed tests conducted at the Fort Mill facility between August 2005 and January 2007. The FDA alleges that more than half of those tests showed the medications to be “gross” out of specifications. The affidavit also says the Leiner should have issued several recalls over the past two years after tests raised doubts about the expiration dates on several of the company’s drugs.
The affidavit also accuses Leiner’s management of ordering its personnel to change data so that the test results appeared normal. The FDA says that the company’s upper management pressured its employees to “use any means necessary to get the product released quickly,”, and the agency alleges that upper management received bonuses for reaching product release quotas. At least one lab analyst told the FDA that employees were instructed to ignore impurities in drugs that were revealed by testing, and to change test parameters to “see what they wanted to see”. Another employee told the FDA that it was “just common knowledge” that impurities found in products could be ignored.
For its part, Leiner Health Products is maintaining that violations were the result of employees at the Fort Mill facility ignoring company standards. Leiner claims to have identified and fired the workers responsible for the violations at the Fort Mill factory.
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