Warning Letter: Informal documentation in emails and on a spreadsheet (ucm458008)


Ofni Systems

Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g).

“From 11/9/2014-5/25/2015, a total of 125 complaints were received and documented informally in emails and on a spreadsheet.  Complaint form, #211.2.A, which is required to be completed per your Complaint Handling procedure, was not completed for each of these complaints…

Data sources are not being analyzed to identify existing and potential causes of nonconforming product or other quality problems, as required by 21 CFR 820.100(a)(1)…

Your response is not adequate.  Although it states that data sources will be reviewed by management on a regular basis as part of management review, you do not address conducting a retrospective review of these data sources to determine if there are any existing and potential causes of nonconforming product or other quality issues that have not been identified.  Also, you did not provide a copy of the applicable procedures that address the type of statistical analysis that will be performed on each data source.”

View the original warning letter.


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