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21 CFR 211.192 : This section is highlighted due to failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed)

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doi: 10.1080/19490976.2023.2281360, 16 CaiT.ZhengS

For example, some craft beers can have an alcohol content as high as 10%, which means that one beer could be equivalent to two or even three standard drinks