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For disorders in which the defective gene is known, a combination of mutation analysis and biosynthetic studies is used to understand the mechanisms by which the mutations arise, the inheritance pattern of each disorder, and the effect of each mutation of the synthesis, structure, and function of the encoded protein

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Non-Conformance 1: Failure to Adequately Investigate Deviations and Batch Failures Regulatory Citation: 21 CFR 211.192 FDA identified a systemic breakdown in the firms investigation process , particularly where contamination events intersected with batch disposition decisions