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BEAVERTON, Ore., Sept. 22 /PRNewswire/ -- Epitope, Inc. (Nasdaq: EPTO) today announced that it received an FDA warning letter in which the agency notes that Epitope has not fully adhered to FDA Current Good Manufacturing Practices guidelines (CGMP), also called Quality Systems Regulations (QSR). The items cited in the letter mainly address incidences relating to strict adherence to standard operating procedures in the production and evaluation of products manufactured by Epitope. The inspection that resulted in the warning letter was the first conducted at Epitope since the new Quality Systems Regulations (QSRs) went into effect on June 1, 1997. These new regulations are part of an industry wide standard that the FDA has adopted to optimize compliance through more rigorous and detailed inspection requirements of companies operating in regulated biologics industries. John Morgan, President and Chief Executive Officer, commented, "While we are taking all of these observations very seriously, it is our belief that none of the observed deficiencies affected the safety or effectiveness of our products. Epitope is cooperating fully with the FDA to address all of the deficiencies cited. We have already replied to each of the FDA's questions and are aggressively making changes in our procedures and retraining our personnel to ensure strict adherence to all standard operating procedures. We believe that the cost of compliance to the Company to make the FDA required changes will be negligible." Morgan continued, "The issues raised in this communication are addressable and should be resolved with the FDA, without significant controversy. We believe that implementing these changes will enable us to operate more efficiently and ultimately to the highest standards of the FDA for product safety and effectiveness. We will continue to work diligently to adopt these new industry wide regulations. Under the new 'team biologics' approach, we believe that the FDA is much more compliance driven and as a result are raising these and other issues with the majority of companies with whom they are inspecting." The Company also noted that the inspection has not caused any production or shipping delays, nor has it affected product sales. Epitope, Inc. develops and markets medical diagnostic products. The company's principal products, including the OraSure oral specimen collection device, focus on the use of oral fluid to detect HIV infection and other conditions, and are marketed primarily in the life insurance and public health sectors. Statements in this press release about future sales levels or other future events or performance are forward-looking statements. The Company's actual results could be significantly different. Factors that could affect results include the extent of future use of oral testing and OraSure in the insurance industry; ability of the company to develop product distribution channels; development of competing products; changes in federal or state law or regulations; and loss of key personnel. Although forward-looking statements help to provide complete information about the company, readers should keep in mind that forward-looking statements are much less reliable than historical information. Source: EPITOPE Inc. Content of this page is copyright and reprinted here for educational and historical information. |
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