Warning Letter: Complaints closed without investigation (ucm42084)

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Ofni Systems

Your firm’s CAPA trending of production hardware failure non-conformances is inadequate in that 39 production hardware failure non-conformances reviewed found you stated a justification for not opening a CAPA for each of these non-conformances as “NCMRs are trended periodically and CAPAs are issued according to this trending.”

View the original warning letter.


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