Johnson & Johnson in the hot seat again, as the U.S. Food and Drug Administration (FDA) just issued a warning to Johnson & Johnson’s DePuy Orthopaedics for marketing a number of unapproved medical device components.
The drug and device giant’s subsidiary sold more than a dozen different orthopedic devices without ever having received required regulatory approval, said the FDA in a just-released warning letter, wrote the Asbury Park Press. The letter also said that DePuy had a quality system in place that was not in compliance with FDA mandates.
The letter, from Steven D. Silverman, FDA’s director of the office of compliance, was sent December 8, 2011 and followed an inspection that took place May 10, 2011 – June 7, 2011 said the Asbury Park Press. In his letter, Silverman said that DePuy manufactured 14 devices, that never received pre-market clearance or approval from the agency.
The products included devices for ankle, knee, hip, shoulder, elbow and wrist replacements.