Home » FDA Issues MJM Warning for Misbranding and Non-Reporting
FDA Issues MJM Warning for Misbranding and Non-Reporting
August 19, 2005
The FDA recently determined some of MJM International’s medical devices to be misbranded under the Federal Food, Drug, and Cosmetic Act as a result of inspections the agency conducted in August 2004 and February 2005. MJM was given notice of these violations in an FDA warning letter dated July 21 and released Aug. 9 for — among other issues — its failure to submit a report of death, serious injury or malfunction to the agency within the 30-day required timeframe after the occurence of a patient death involving one of MJM’s mechanical walkers.