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[DOI] [PubMed] [Google Scholar] 94.Barabanova S.V., Artiukhina Z.E., Ovchinnikova K.T., Abramova T.V., Kazakova T.B., Khavinson V.K., Malinin V.V., Korneva E.A
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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
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