Welcome to

Epitope Responds to FDA Warning Letter

    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
    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

Source: EPITOPE Inc.

Content of this page is copyright and reprinted here for educational and historical information.
Copyright 2004 - 2018 - Ekim Notnud - All rights Reserved
This site is an unofficial historical site and not affiliated with Epitope, Inc.

  Click for Heirloom Tomato Seed Selection Victory Seed Company Save Seeds - Victory Horticultural Library