Thursday, March 10, 2011

FDA-ordered quality control at $JNJ

Johnson & Johnson subsidiary McNEIL-PPC Inc signed a consent decree with the U.S. Food and Drug Administration covering manufacturing facilities in Puerto Rico and Pennsylvania.


Under the terms of the Consent Decree, the company will continue to operate the manufacturing facilities in Las Piedras, PR and Lancaster, PA. The company will work with an independent expert who will inspect these sites and issue recommendations. Based on these findings, the company will develop remediation plans to address observations identified by the independent expert. These plans will be submitted to the FDA and are subject to the agency's approval. In addition, the company and the FDA have agreed on a plan to have the independent expert review certain manufacturing records at the two sites while remediation is ongoing to ensure that products released from the sites continue to meet quality standards. The company expects that the Consent Decree will govern the company's operation of the facilities for a period of at least five years following the completion of the remediation plan.

Sources
JNJ.com 
mcneilproductrecall.com

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