J&J warned over illegal hip, knee device sales

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney.com) -- The Food and Drug Administration has hit another Johnson & Johnson unit -- medical device maker DePuy Orthopaedics -- with a warning letter for selling hip and other joint products without the agency's approval.

The FDA said in the letter that the company has been selling its TruMatch Personalized Solutions System, which makes artificial knee products, and the Corail Hip System without "market clearance" and in violation of the Federal Food, Drug, and Cosmetic Act.

The agency said DePuy should immediately stop selling the Corail products or face further enforcement action, which could include product seizure, injunction or civil penalties.

The FDA said it will only evaluate whether these products can be legally marketed to consumers after DePuy submits information for approval.

Johnson & Johnson (JNJ, Fortune 500) has come under intense FDA scrutiny over the past year.

The company's McNeil Consumer Healthcare unit, which makes well-known cold and pain drugs such as Tylenol and Benadryl, has received negative inspection reports and warning letters tied to manufacturing lapses at its U.S. factories.

In May, McNeil shut a plant in Fort Washington, Penn., after the company recalled millions of children's Tylenol and other drugs that were made at that facility.

In this latest warning letter, the FDA has given Depuy 15 days to correct the violations.

DePuy Orthopaedics says it is "reviewing the letter to understand the FDA's concerns and will respond to their request for information." To top of page

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