FDA Warns Irisys Over Production Process Issues

Law360, New York (September 22, 2010, 3:14 PM EDT) -- The U.S. Food and Drug Administration has issued a formal warning to Irisys Inc. over alleged problems with its drug production process, saying the company does not have procedures in place to ensure its products pass muster.

The cited problems, described in a letter released Tuesday, surfaced after a March 16 to April 1 inspection of Irisys' manufacturing facility in San Diego.

Beyond the problems with its manufacturing controls, Irisys is also marketing a drug called Treagan Otic, normally used to treat the pain associated with...
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