Warning Letter: Failure to maintain accurate records (ucm147820)

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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.

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