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Violation of 211.84 - the typical wording in the warning letters and the facts The content of the warning letters was analyzed using a 4-part topic-related presentation according to the following structure: the description of the GMP violation the Company's response the FDA's feedback the follow-up requests for documents/evidence from the FDA This format - an extract from the text of the warning letter - offers the advantage of a topic-centered approach, as the following two examples illustrate: Example 1 You failed to perform adequate identity testing for each component lot used in the production of your hand sanitizer drug products, including ethanol, your active pharmaceutical ingredient

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