Warning Letter: Lack of validation testing (s6906c)

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Ofni Systems

Your validation of your device design is incomplete in that the firm has not established a protocol for conducting validation testing and did not validate the software to ensure that devices conform to the defined user needs and intended uses, as required by 21 CFR §820.30(g). Specifically, you have made 1,900 revisions to the software in three years without conducting validation testing .

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