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Based on these reports, we decided to investigate whether the administration of coffee enemas would have the effect on bile excretion

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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

So even though it's not a steroid or hormone, uh, if you are on it and you are competing, [00:23:00] uh, professionally or at a high level, you are going to, uh, you're going to light up positive for this