J&J Unit Signs Consent Decree for U.S. Facilities

McNeil-PPC, Inc., a Johnson & Johnson subsidiary, has finalized the terms of a Consent Decree with the FDA. The decree covers manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, PR, Fort Washington, PA, and Lancaster, PA. The Consent Decree is subject to approval by the U.S. District Court of Pennsylvania.

In July 2010, McNeil submitted a Comprehensive Action Plan (CAP) to improve quality systems at its U.S. manufacturing facilities. McNeil believes that the terms of the consent decree recognize remediation efforts to date, consistent with its commitments as part of the CAP.

Under the terms of the consent decree, the company will continue to operate the manufacturing facilities in Las Piedras, PR and Lancaster, PA and will work with an independent expert who will inspect these sites and issue recommendations for remediation to address any observations identified. These plans will be submitted to the FDA and are subject to the agency’s approval. The independent expert will also review certain manufacturing records at the two sites while remediation is ongoing to ensure quality standards of products released from the sites. The company expects that the consent decree will oversee its operations for at least five years following the completion of the remediation plan.

In April 2010, the company voluntarily closed its manufacturing facility in Fort Washington, PA and announced that it would not re-open the plant until it completed remediation efforts at that facility.