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  • Warning Letter: Failure to validate processes (ucm076566)

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    Ofni Systems

    Failure to validate manufacturing processes and approve according to established procedures, where the results cannot be fully verified by subsequent inspections and tests. [21 C.F.R. 820.75(a)] Specifically: Computer Numerical Control (CNC) Machine #C-4 had out of specification results during operational qualification conducted during validation. These out of specification results were not investigated or addressed in the validation report.

    View the original warning letter.


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