Warning Letter: No Corrective Action validation plan (ucm332838)

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Ofni Systems

Your firm had not completed any corrective or preventive actions and had not evaluated the effectiveness of your supplier’s corrective actions… E.    Failure Investigation and Corrective/Preventive Action Form No. 497, dated 08/02/2011, stated that DPM Central Station had a software anomaly which caused the trend data for a patient to be replaced by another patient.  On 05/12/2011, your firm released a product correction letter to the field to correct the issue via a software upgrade.  The CAPA effectiveness verification method was identified as verifying that all documents in the corrective action have been modified.  However, your firm was not able to provide any documentation to demonstrate that the CAPA has been verified for effectiveness and that it does not adversely affect the finished device.

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