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[DOI] [PubMed] [Google Scholar] 27.Matsushita T, Kusakabe Y, Kitamura A, Okada S, Murase K

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

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Because injections bypass the digestive tract, they are particularly helpful for individuals who may have impaired absorption