Johnson & Johnson subsidiary, DePuy Orthopaedics Inc., sold more than a dozen types of orthopedic devices without getting approval from regulators, the U.S. Food and Drug Administration stated in a warning letter. The FDA also found that the company's quality system did not comply with all FDA requirements.

DePuy has come under fire for their hip-replacement device, the ASR XL Acetabular Hip Replacement System. DePuy has recalled the device and is paying for new surgeries after a database found that the device failed in 13 percent of patients who received the device. DePuy's defective hip replacement devices have a very high rate of failure compared to other hip-replacement devices.

The FDA warning letter sent to DePuy stated that the company had made 14 knee and hip devices that didn't receive pre-market clearance or approval from the FDA. The company stated that they believed that since the devices were custom-made for each patient's physical anatomy and was exempt from the FDA approval process. A DePuy spokesperson said that the company believed they had complied with FDA requirements. However, the FDA said they did not meet the criteria to be exempt since the finished devices could be available to other doctors.

The FDA also cited DePuy for failure to comply with the following quality regulations:

•· Company did not have adequate procedures to ensure devices conformed to user's needs

•· Did not have adequate procedure to review complaints

•· Did not ensure employees in charge of nonconformance was notified when a product wasn't in conformance

A DePuy spokesperson stated that the company has taken several actions to address the concerns of the FDA.

Source: Asbury Park Press, "FDA says Johnson & Johnson subsidiary DePuy sold orthopaedic devices without approval," Jan. 18, 2012