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OraSure Addresses FDA Warning Letter on DNA Genotek


OraSure Technologies (Nasdaq: OSUR) announced that its molecular collection systems subsidiary, DNA Genotek, received a warning letter from the U.S. Food and Drug Administration (FDA) which the FDA posted today on its website. The warning letter primarily focuses on DNA Genotek's response to two observations issued by the FDA on Form 483 as a result of a routine inspection of DNA Genotek's Ottawa, Canada facilities in September 2013.

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Posted-In: News Guidance Offerings FDA Management Global


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