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CryoLife Inc. Message Board

  • dlhild Mar 14, 2013 4:02 PM Flag

    FDA Warning Letter Part 1:

    FDA Warning Letter Part 1:

    On January 29, 2013, the FDA sent a warning letter to Cryolife (NYSE: CRY):

    Steven G. Anderson, CEO
    Cryolife, Inc.
    1655 Roberts Blvd, NW
    Kennesaw, Ga 30144

    Dear Mr. Anderson:

    During an inspection of Cryolife Inc., conducted at 1655 Roberts Boulevard on September 17 – October 16, 2012, investigators from the U.S. Food and Drug Administration (FDA) determined that your firm manufactures various medical devices. These products are devices within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 321(h)] in that they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

    This inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act [21 U.S.C. § 351(h)] in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulations found at Title 21 of the Code of Federal Regulations Part 820 (21 CFR Part 820).

    A form FDA 483, Inspectional Observations, was issued to David Fronk, Vice President Regulatory Affairs and Quality Assurance, at the close of the inspection (copy enclosed). We have received your firm’s response letters dated November 6, 2012; December 5, 2012; and January 14, 2013 concerning our investigators’ observations identified on the FDA 483. We address these responses below, in relation to each of the noted violations. The violations documented on the FDA 483 issued include, but are not limited to, the following:

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