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FDA warns J&J’s DePuy unit over joint replacements – AlertNet.

FDA warns J&J’s DePuy unit over joint replacements

18 Jan 2012 23:21

Source: reuters // Reuters

WASHINGTON, Jan 18 (Reuters) – U.S. health regulators have warned Johnson & Johnson‘s DePuy Orthopaedics Inc unit against selling joint replacement products without proper approval, prompting the company to stop making some devices.

A Food and Drug Administration warning letter to DePuy dated Dec. 8, 2011, said an on-site federal investigation showed the company was selling 14 products without proper approval from DePuy’s facilities in Warsaw, Indiana. The agency released the letter this week.

The products included devices for ankle, knee, hip, shoulder, elbow and wrist replacements.

The letter threatened possible regulatory action, including seizure, injunction and financial penalties and gave DePuy 15 business days to correct the violations.

DePuy has already been at the center of a massive recall of artificial hips after they were shown to fail at a higher-than-expected rate.

A statement released by DePuy on Wednesday said the company produced the items as custom medical devices for physicians. Custom devices are exempt from the rules the FDA cited in the warning.

But the agency said the products were too standard in design to qualify for exemption.

“While DePuy believes it had complied with FDA requirements, the company has made the decision at this time not to provide custom devices,” the company statement said.

The FDA also warned DePuy had failed to establish adequate design procedures to ensure the devices conformed to their intended use. The agency also said the company lacked a proper statistical method for detecting recurring quality problems.

“DePuy has implemented a number of actions to address concerns raised in the inspection, and has responded to all concerns raised in the warning letter,” the company statement said. (Reporting By David Morgan; editing by Andre Grenon)