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14 Mar 2011

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

Under the terms of the consent decree, the company will continue to operate the manufacturing facilities in Las Piedras, PR and Lancaster, PA.

McNeil-PPC, Inc., a Johnson & Johnson subsidiary, has completed the terms of a Consent Decree with the FDA. The decree covers manufacturing facilities operated by the McNeil Consumer Healthcare Division in Fort Washington, PA, and Lancaster, PA.

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

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