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Leiner gets FDA warning

FORT MILL -- Leiner Health Products has been issued another warning from the U.S. Food and Drug Administration related to manufacturing practices at its Fort Mill plant, according to a document the drug, vitamin and supplement company filed with the U.S. Securities and Exchange Commission Wednesday.

The warning stems from government inspections in the spring that revealed the facility off Carowinds Boulevard did not meet federal good manufacturing practices, the filing states. The warning letter reiterates the importance of resolving all manufacturing shortcomings, according to the filing. The specific shortfalls have not been made public.

After the initial warning in the spring, Leiner, a supplier of store brand drugs to major retailers, pulled all its over-the-counter products off store shelves. Since then, the company has laid off 500 workers at its Fort Mill plant and reported a net loss of $27.5 million in the first quarter of the new fiscal year.

Leiner Chief Financial Officer Kevin McDonnell declined comment on Thursday when asked how the company would respond to the latest warning.

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