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  • Warning Letter: Failure to test input/output (ucm173977)

    Tags:

    Ofni Systems

    Failure to check input to and output from the computer or related systems of formulas or other records or data for accuracy as required by 21 CFR 211.68 (b). Specifically, duplicate donor records were created when your firm changed from [redacted] Computer System to [redacted] Computer System on December 2, 2008. The duplicate donor records do not always agree regarding donor eligibility status. For example,  The donor cited in Item 1 is assigned a [redacted] donor identification number of [redacted] and has an eligibility status of “indefinitely deferred”. The same donor has a [redacted] identification number of [redacted] and has an eligibility status of “eligible”.

    View the original warning letter.


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