Warning Letter: Inadequate spreadsheet (ucm406826)

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Ofni Systems

Also, your firm tracks complaint data on a spreadsheet that contains free form text fields that are not standardized, resulting in an inability to adequately trend the data. For example, when using complaint data from January 1, 2011 to February 19, 2014 to trend for “Description of Failure” for “6090,” fourteen complaints are shown. However, the spreadsheet contains several different descriptions of the same part failure that when totaled resulted in a total count of forty complaints related to the inline coupler, part #6090.”

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