Johnson & Johnson Unit Issued FDA Warning Letter
On August 19, 2010, the U.S. Food and Drug Administration issued a warning letter to DePuy Orthopaedics, Inc., a business unit of Johnson & Johnson, stating that it is marketing two products without required clearance or approvals in violation of the Federal Food, Drug, and Cosmetic Act. The warning letter was specifically directed at two (2) DePuy Orthopaedics’ products, the TruMatch Personalized Solutions System and the Corail Hip System. The FDA claimed that the TruMatch system did not receive pre-market approval and was misbranded because of the lack of notification to the FDA. Likewise, the Corail Hip System received FDA pre-market notification but was marketed for uses beyond that specific notification. DePuy is required to respond within fifteen (15) days to the FDA’s letter and explain its plan to prevent these violations from occurring in the future and document any corrective action taken.
For more information see: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm223613.htm