Warning Letter: Failure to Automate Data Processing Systems (ucm190816)

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Ofni Systems

You have failed to validate computer software for its intended use according to an established protocol, when computers or automated data processing systems are used as part of the production or the quality system, as required by 21 CFR 820.70(i). Specifically, there is no record of validation for software in the [redacted] which is used to make components for the aspirating dental injection syringes.

View the original warning letter.


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