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Affymax, Inc. (AFFY) Message Board

  • sonay10 sonay10 Nov 22, 2013 12:13 AM Flag

    Interesting Article Part 2

    September 15th, 2011 – FDA Sends Warning Letter to Fresenius

    The FDA sends a warning letter to the Fresenius CEO after their investigation reveals FMC is inadequately addressing complaints filed by patients using the company’s products. The letter addresses five major areas of fault, including “Failure to establish procedures for investigating the cause of nonconformities stemming from incidents pertaining to NaturaLyte Acid Concentrate” and “Failure to establish and maintain an adequate preventative action to ensure identification of actions needed to corrects and prevent problems.”

    November 4th, 2011 – Internal Memo Circulated

    The internal memo, “Dialysate Bicarbonate, Alkalosis and Patient Safety,” is sent out to Fresenius doctors warning of the risks associated with their GranuFlo and NaturaLyte products. In the document it is written that “[the] issue needs to be addressed urgently.”

    March, 2012 – Memo is Leaked to the FDA

    Over four months after the original internal memo was circulated, the memo is anonymously leaked to the Food and Drug Administration (FDA).

    March 29th, 2012 – Fresenius Issues Warning to Doctors

    On March 29th, 2012, Fresenius releases a modified update to the original memo, warning doctors of the dangers associated with its products. The same day, the FDA issues a statement informing the public of the notice. In the statement, the FDA writes, “The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate…This product may cause serious adverse health consequences, including death.” The recall is listed as “voluntary.”

    May 25th, 2012 – FDA Issues Update Warning Doctors of Dosing Dangers

    The FDA releases an update warning doctors of “alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate.” The press release recommends that doct

    Sentiment: Hold

 
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