Warning Letter: Incomplete validation (ucm223938)

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Ofni Systems

Your validation procedure describes your acceptance criteria and states [redacted]. However, your validation report does not address [redacted]. In addition, your testing described in your Validation Protocol [redacted] does not account for detection of [redacted]. Your validation data and results should ensure that all your acceptance criteria are met. In addition, your microbiological results provided with your response do not indicate whether the results reflect [redacted].

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