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Asthma : DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma

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deviations 21 CFR 211.165 - 29 Warning Letters - Testing and release for distribution 21 CFR 211.192 - 27 Warning Letters - Production record review 21 CFR 211.166 - 22 Warning Letters - Stability Testing 21 CFR 211.84 - 22 Warning Letters - Testing and approval or rejection of components, drug product containers, and closures Dive Deeper: Pharmaceutical Quality Assurance: FDA's Quality Unit Expectations 4