Court Lifts FDA Consent Decree with Mentor.Business Editors SANTA BARBARA, Calif.--(BUSINESS WIRE)--Sept. 8, 2003 Mentor Corporation (NYSE NYSE See: New York Stock Exchange :MNT See molecular nanotechnology. ) announced today that the United States District Court United States District Court In the U.S., any of the 94 trial courts of general jurisdiction in the federal judicial system. Each state, as well as the District of Columbia and the Commonwealth of Puerto Rico, has at least one federal district court. in Dallas, Texas vacated the 1998 Consent Decree entered between Mentor and the United States involving Mentor's compliance with FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. current good manufacturing practice Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. requirements at Mentor's Irving, Texas facility. The FDA had recently advised Mentor that it would not object to Mentor's request to the Court to vacate the Decree. As a result, the Court dismissed this case, which was initiated in 1998. The 1998 Consent Decree provided that if Mentor (and its co-defendants) maintained a state of continuous compliance with the Decree for five years, the FDA would not oppose dissolving the Decree. In the five years since the Decree was entered, Mentor has worked closely with the FDA to ensure the company's compliance with applicable legal requirements. Mentor has satisfied the Agency's requirement that Mentor's Irving, Texas facility be in continuous compliance for at least five years with the FDA's current good manufacturing practices requirements. "We are very pleased that the Court has vacated the 1998 Consent Decree. We are particularly gratified grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. that our dedication over the past five years to ensuring that Mentor complied with all applicable FDA requirements has paid off. Indeed, our working relationship with the FDA has been strengthened due to the showing we made to the Agency. As a result, we were able to represent to the Court that the FDA did not oppose the granting of our Motion to Vacate the Consent Decree," said Chris Conway, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Mentor Corporation. "It is already a great success for our company and demonstrates that as we move forward, we expect to continue to have an outstanding working relationship with the FDA." Mentor Corporation develops and manufactures specialized medical products, which it markets throughout the world. This release contains, in addition to historical information, forward-looking statements. Such statements are based on management's current expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2003. |
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