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  5. FDA warning letter - Wikipedia

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    When adequate notice has been given by other means and the violations have not been corrected, or are continuing. In certain situations, the agency may take other actions instead of, or concurrent with, a Warning Letter. For example: [3] The product is adulterated under Section 402(a)(3) or 402(a)(4) of the Act; There is a violation of cGMP;

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