Johnson & Johnson Provides Update on McNeil Consumer Healthcare Remediation; Announces Completion of Internal Assessment Phase Of Comprehensive Action Plan
McNeil Consumer Healthcare Division of McNeil-PPC, Inc., a Johnson & Johnson company, in July 2010 submitted to the FDA a Comprehensive Action Plan on quality improvement, and made a commitment to restore its operations to the level of quality and compliance that people expect of all Johnson & Johnson companies. As part of this commitment, McNeil undertook a thorough investigation of historical records, as far back as 2007, for products sold in the U.S. and produced in McNeil's internal manufacturing network. For each product, McNeil looked at whether the right processes had been identified and followed, and evaluated whether quality standards had been met. This assessment has now been completed, representing a significant milestone in the Comprehensive Action Plan.
The assessment identified a number of areas for improvement, which are being addressed. For example, McNeil identified instances where equipment cleaning procedures were insufficient or cleaning was not adequately documented. These issues occurred at McNeil's Fort Washington, PA manufacturing plant, prior to April 2010, when production at the facility was suspended. McNeil also discovered one product for which the labeling did not include all information required by regulations. In line with the company's unqualified commitment to quality and compliance, McNeil today announced a wholesale-level recall of products affected by these issues. (Click HERE to access recall information.) This recall does not come as a result of adverse events.
Johnson & Johnson Chairman and CEO Bill Weldon said, "Steps we have taken under the Comprehensive Action Plan constitute an uncompromising and systematic effort to review quality and manufacturing practices at McNeil. They help us assure that moving forward, any of our products in the marketplace live up to the trusted standards and expectations that consumers have for all products coming from a Johnson & Johnson company, anywhere in the world."
As a continuing part of this effort, McNeil is conducting assessments at other sites that manufacture its products. If these reviews reveal any further issues, McNeil will not hesitate to take whatever steps are needed to ensure that its products meet world-class quality standards, including further market action if warranted.
McNeil is committed to ensuring the highest levels of quality, and to restoring recalled products to the market so they will be available to the people who rely on them.