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Johnson & Johnson (JNJ) Sterilization Unit To Pay $1.25 Million For FDA Violations



12/5/2013 7:13:33 AM

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Advanced Sterilization Products, a division of Johnson & Johnson's Ethicon unit, agreed to a $1.25 million settlement with the U.S. Food and Drug Administration over allegations that it sold adulterated and misbranded monitoring products, the agency said on Wednesday. The FDA said Advanced Sterilization will pay $1.2 million, while company President Bernard Zovighian will pay $30,000 and Richard Alberti, vice president of quality and regulatory compliance, will pay $20,000. The agency said the company knew that it did not have sufficient data to support the labeled shelf life of a product used to monitor and confirm the effectiveness of the process in certain sterilizers.

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