OTI received a warning letter in connection with a FDA

Entities Mentioned

• OPKO Health
• OTI Ophthalmic Technologies Inc.
• Ophthalmic Technologies OCT/SLO

1. 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. ... (Read Full Article)
   
   

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