• (919) 844 2494
  • Warning Letter: Failure to maintain accurate records (ucm147820)

    Tags:

    Ofni Systems

    Your firm failed to maintain complete and accurate records from which unsuitable donors could be identified so that products from such individuals would not be distributed [21 CFR 606.160(e)] and records to identify the person performing the work so to provide a complete history of the work performed [21 CFR 606.160(a)(1)]. Specifically, when the investigators requested a search of some of the various donor permanent deferral codes in your [redacted] database, 72 donors had various permanent deferral codes entered into the “Comment” field but these donors did not have a permanent deferral status entered into the “Deferral Code” field of the [redacted] database. The “Comment” field is not referenced for identification of deferred donors. Out of 72 donors, 10 were verified to meet the criteria for permanent deferral.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>