The McNeil unit of J&J has made serious errors in its response to FDA's warning letter of of consumer complaints about its Tylenol arthritis caplets. Reminscent of the recent problems at Toyota which like J&J had been a leader in product safety and quality, J&J has mismanaged the FDA complaint. In January the FDA sent a warning leter to McNeil that it had failed to investigate properly consumer complaints made since 2008 of a musty odor from the bottles of Tylenol Arthritis caplets. The source of the problem lies in failure of quality control in its manufacturing facilities. McNeil is now conducting a comprehensive review of its quality management systems. McNeil has identified the cause of the smell as the breakdown of a preservative, used to treat wooden transport pallets, that had leached into the products at a company plant in Las Piedra, Puerto Rico.