The U.S. Department of Justice is investigating whether Leiner Health Products committed wrongdoing in the way it produced and distributed over-the-counter drugs at its Fort Mill facility, the company said Tuesday.
In a filing with the Securities and Exchange Commission, Leiner said it "intends to cooperate fully" with the probe.
A company spokesman could not be reached for comment Tuesday evening. A Department of Justice spokesperson said the agency does not comment on ongoing investigations.
Tuesday's announcement represents the latest chapter in a saga that has unfolded from California to Fort Mill over recent months.
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In Tuesday's filing, the company said it believes the Justice Department investigation is related to a previous inspection of the Fort Mill plant by the federal Food and Drug Administration. The FDA inspection discovered deficiencies in the facility's manufacturing practices and resulted in the suspension in March of over-the-counter drug production throughout the company.
A company official said the problems were mostly related to shelf-life issues.
Troubles began in April
In April, Leiner recalled all of its over-the-counter products.
Also in April, Leiner CEO Bob Kaminski said the FDA inspection was launched after an employee at the Fort Mill facility called federal agents about problems with the company's lab practices.
In June, Leiner announced it would lay off about 540 workers at the Fort Mill plant, shutting down manufacturing and packaging operations and keeping about 35 people on for distribution.
Leiner learned of the Justice Department inquiry on Sept. 5, according to Tuesday's SEC filing.
The California-based company is the nation's second-largest supplier of over-the-counter pharmaceuticals in the food, drug, mass merchant and warehouse club retail market. Wal-Mart, Sam's Club and CostCo are three of its biggest customers.
The company also makes store-brand vitamins, minerals and nutritional supplements.
Leiner opened a $40 million, 680,000-square-foot facility in York County in 1998. The facility, once one of the county's largest employers, is located in Fort Mill's Lakemont Business Park off Carowinds Boulevard.
Leiner officials have said they are confident the company is doing all it can, including retesting its products, to meet and exceed quality standards. Leiner hopes to stay a major player in the OTC market, executives said, although vitamins and supplements are the company's "bread and butter."