Warning Letter: Failure to maintain adequate procedures (ucm200878)

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Ofni Systems

Failure to establish and maintain adequate procedures to identify all the action(s) needed to correct and prevent the recurrence of nonconforming products and other quality problems, as required by 21 CFR 820.100(a)(3). For example: You have decided to issue a software update as a corrective measure for resistor related issues. However, our review indicates that the latest software update is only a method of detection and will not prevent resistor failures.  “Failure to review and evaluate all complaints to determine whether an investigation is necessary and maintain a record that includes the reason when no investigation was made, as required by 21 CFR 820.198(b).

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