Note 17 Subsequent Events
On March 25, 2008, OTI received a warning letter in connection with a FDA
inspection of OTI's facilities in July and August of 2007. The warning letter
cited several deficiencies in OTI's quality, record keeping, and reporting
systems relating to certain of OTI's products, including the OTI Scan 1000, OTI
Scan 2000, and OTI OCT/SLO combination imaging system. Based upon the
observations noted in the warning letter, OTI is not currently in compliance
with cGMP. The FDA indicated that it has issued an Import Alert and may refuse
admission of these products. As a result, we will not be permitted to sell
these devices in the United States, and the pre-market approval application for
the Company's OCT/SLO product will be delayed until the violations have been
corrected.
We plan to cooperate fully with the FDA, and upon receipt of the warning letter,
we immediately began to take corrective action to address the FDA's concerns and
to assure the quality of OTI's products. We are committed to providing high
quality products to our customers, and we plan to meet this commitment by
working diligently to remedy these deficiencies and to implement updated and
improved quality systems and concepts throughout the OTI organization.
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