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CryoLife Inc. Message Board

  • dlhild@ymail.com dlhild Mar 14, 2013 4:01 PM Flag

    FDA Warning Letter Part 2:

    FDA Warning Letter Part 2:
    1. Failure to ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).

    Specifically,

    a. The coupons used in the "Disinfectant Efficacy Verification for Hard Surfaces" VP-2008-065-PV approved: 04/26/2010, were not representative of the surfaces found in the Tissue Processing Laboratories (TPL) and BioAdhesive laboratories. For example, (b)(4) was used in the study to represent the biological safety cabinets, laminar flow hoods, and tables in the processing and manufacturing areas. However, the equipment is comprised of (b)(4).

    Your response to this observation appears adequate; however, we are unable to determine if this response is adequate without review of the final summary with the included data for VP-2008-065-PV, Addendum 3, "Disinfectant Efficacy Verification for Hard Surfaces." This information will be reviewed during the next establishment inspection.

    b. All surfaces that are used in critical processing and manufacturing areas were not evaluated in the "Disinfectant Efficacy Verification for Hard Surfaces" VP-2008-065-PV approved: 04/26/2010.

    Your response to this observation is not adequate. The (b)(4) work-top surface is an area that is monitored and is located in a classified area. Therefore, the effectiveness of its cleaning should be evaluated just as the other surfaces.

    2. Failure to document corrective and preventive actions and their results, as required by 21 CFR 820.100(b). Specifically,

    a. The environmental action trending reports for 4th quarter 2011 and 1st quarter 2012 omitted the trending of alerts prior to the approval of your procedure titled "Environmental Trending".

    Your response to this observation is inadequate. The 4th Quarter 2011 environmental action trending report was generated prior to the approval of SOP NL

 
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