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 FDAand are subject to the agency's approval. In addition, the company and the FDAhave 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.