Warning Letter: Failure to establish validation procedures (ucm268244)

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Ofni Systems

Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation are documented in the design history file, as required by 21 CFR 820.30(g). Specifically, Validation of device software was not performed.

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