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CryoLife Inc. Message Board

  • dlhild Mar 14, 2013 3:57 PM Flag

    FDA Warning Letter Part 5:

    FDA Warning Letter Part 5:

    5. Your firm’s personnel do not have the necessary training to perform their jobs, as required by 21 CFR 820.25(a). Specifically,

    a. Poor aseptic techniques were observed of Microbiology Technician performing sterility testing on 9/19/2012.

    b. Employee's head covering was not properly attired during the filling process of BioGlue Adhesive (b)(4) while working in the fume hood in the (b)(4) work area of Room #3070 on 9/18/2012.

    c. Employees were not trained on the validation requirements prior to protocol executive as outlined in VP-2009-007-EQ/PV, Equipment Qualification and Process Validation of the (b)(4) Heat Sealer. Employee (b)(4) performed packaging operations for the validation. Training is not documented as required in the protocol.

    Your responses to these observations are inadequate. Your response letters fail to identify corrective actions your firm has implemented to prevent the recurrence of this observation.
    6. Failure of management with executive responsibility to review the suitability of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of this part, as required by 21 CFR 820.20(c). Specifically,

    a. Environmental Trending was not performed as stated in SOP NL0026, revision 000 effective date: 10/28/2009, and revision 001 effective date: 12/28/2011 "Environmental Trending." The management group did not attend quarterly trending meetings to identify or respond to trends observed during 3rd and 4th quarter 2009 and 1st through 4th quarter of 2010 and 2011. Additionally, the internal audit system failed to identify that environmental trending was not performed until the 4th quarter of 2011.

    Your response to this observation is inadequate. Your response letter fails to identify corrective actions your firm has implemented to assure the reoccurrence of this observation.

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