Copley Pharmaceuticals of the USA, which has pleaded guilty to a federalcharge of criminal violations in manufacturing processes and agreed to pay $10.6 million (Marketeletter June 9), will take a charge in the second quarter of this year of $2 million, or 10 cents per share, to cover the fine, and will revise its reserve for product recall and litigation expenses.
The company admitted to changing manufacturing methods for a number of different products without informing the US Food and Drug Administration of its actions. A US attorney said that the company's conduct created the possibility of the products being "unsafe, ineffective, or both."
Copley commented that it is pleased to have the inquiry behind it and added that the three-year investigation found no evidence that anyone suffered any injury as a result of the company's conduct.
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