J&J To Restructure Quality Controls Oversight

Johnson & Johnson plans to overhaul its quality controls, creating a single support program for its pharmaceutical, medical device and consumer health care divisions. Ajit Shetty, corporate vice president responsible for supply chain operations, will oversee the new system, reporting to William C. Weldon, J&J’s chief executive officer. The company also plans to appoint chief quality officers for each of its three major divisions.

The quality control reorganization is in response to a number of recent recalls of Tylenol, Motrin and other products by McNeil Consumer Healthcare, a unit of J&J. The recalls have led to the temporary closing of J&J’s Fort Washington, PA manufacturing plant.

In April, McNeil recalled an estimated 136 million bottles of liquid children’s Tylenol and other products made at the Fort Washington plant. According to the company, the products were recalled because they might have contained too much of the active drug ingredient or foreign particles.

In the last two years, FDA inspectors found violations of manufacturing standards at two McNeil plants. In January, McNeil recalled millions of bottles of adult Tylenol, Motrin and other products made at a company plant in Puerto Rico after consumers complained about a moldy or musty odor in the products. The company said a byproduct of a chemical used to treat wooden transport pallets had leached into the products, causing the moldy smell.