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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