In a new setback to Johnson and Johnson, two products manufactured at the American pharmaceutical manufacturer’s units were reported illegal by the U.S. Federal Food and Drug Administration.
The warning was sent to DePuy Orthopedics Incorporation, informing the Company that the FDA would require the J&J unit to stop its manufacturing line for these two specific products until further notice, thus giving FDA some time to consider the information sent by DePuy.
The warnings were mainly regarding the Company’s selling two products, one of them the TruMatch Personalized Solution System, which has never been approved for sale by the FDA, and the other Corail Hip System, which is being marketed for two uses. The FDA granted DePuy a 15-day notice to fix their violations.
In addition, the FDA’s warning letter included further information in case the Company failed to deal with the violations. The letter stated, "Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and or civil money penalties".