McNeil Consumer Healthcare, a business unit of Johnson & Johnson (New Brunswick, NJ), failed to ensure the quality of over-the-counter consumer products, according to the Form 483 report released by the US Food and Drug Administration on Wednesday. FDA inspected the Fort Washington, Pennsylvania, plant from Oct. 27, 2010, to Dec. 9, 2010. Inspectors also observed that consumer complaints were not investigated well and that poor record keeping was a problem at the facility.

The manufacturing plant was closed in April following massive recalls of more than 40 types, and 135 million bottles, of infants’ and children’s medicines on April 30, 2010, due to contamination and substandard quality. The April 30th recall was also the subject of a hearing by the House Committee on Oversight and Government Reform in May. J&J responded by presenting an action plan to FDA in July outlining how to improve product quality. The company also appointed a corporate head of quality in August that reports directly to the CEO.

The company has issued numerous additional recalls related to product quality in the past year, the most recent was the last week’s voluntary recall of Rolaids products after consumer reports found wood and metal particles in the tablets.

McNeil has also had problems with quality in Puerto Rico. In January 2010, FDA issued a Warning Letter to McNeil for “significant violations of the Current Good Manufacturing Practice (CGMP) regulations” at its facility in Sector Montones, Las Piedras.

Executive Appointments
J&J expanded the office of the chairman Wednesday by adding two new positions. The company appointed Alex Gorsky, currently worldwide chairman of medical devices and diagnostics, and Sheri McCoy, currently worldwide chairman of pharmaceuticals, to the positions of vice-chairmen of the executive committee, effective Jan. 3, 2011. Gorsky will have the added responsibilities of the medical device and diagnostics group, global supply chain, and government affairs and policy. McCoy will oversee the pharmaceuticals group, consumer group, the corporate office of science and technology, and corporate affairs.

“These appointments will ensure we are well-positioned for sustainable growth into the future,” said William C. Weldon, chairman and CEO. “The changes are an appropriate step in furthering our long-term succession plans, and assuring talented, experienced leaders at all levels of the organization.”

The move appears to indicate that the beginnings of a succession plan is in place—the New York Times and other news outlets are calling the two promotions a “horse race” to determine who will take over as CEO. Although Weldon has faced criticism for his handling of the company’s recent quality problems and pressure to step down from his position, a company spokeswoman told NYT that Weldon “has no plans to retire.”

Click here to view a list of previous PharmTech blog posts about J&J.