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    Sharaz
    Spectator

    Extract from BIOLASE News Page:

    No Material Impact on Operating Results Anticipated

    IRVINE, CA, Sep 11, 2006 (MARKET WIRE via COMTEX News Network) — BIOLASE Technology, Inc. (NASDAQ: BLTI), a medical technology company that develops, manufactures and markets lasers and related products focused on technologies for improved applications and procedures in dentistry and medicine, announced today that on September 7, 2006, it received a Warning Letter from the Los Angeles District Office of the United States Food and Drug Administration (“FDA”) following an inspection of the Company’s Irvine, California facility in August 2006.

    The Warning Letter indicates that certain aspects of the manufacture, packing, storage or installation of the Company’s devices are not in conformance with the FDA’s current Good Manufacturing Practice requirements for medical devices. A substantial portion of the identified issues relate to actions or inactions that occurred prior to 2006, some of which continue to date. The Warning Letter instructs the Company to take prompt action to address the concerns and states that failure to do so may result in regulatory action being initiated by the FDA. Until the Company resolves this matter to the satisfaction of the FDA, certain government requests will not be granted or approved.

    Jeffrey W. Jones, president and chief executive officer, commented on the development, “Compliance with FDA guidelines is taken very seriously at BIOLASE and we have given this matter the highest priority within the organization. We are working very cooperatively with FDA representatives to take any necessary action to expeditiously resolve all of the cited matters to their satisfaction. We do not anticipate that this matter or its resolution will have any material impact on our operating results.”

    ……………..ooooops!

    (Edited by Sharaz at 3:12 am on Sep. 19, 2006)

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