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FDA Warning Letter

Meaning

An FDA Warning Letter is an official, formal communication issued by the U.S. Food and Drug Administration (FDA) to regulated entities, such as pharmaceutical manufacturers or dietary supplement companies, that are found to be in significant violation of federal regulations. This letter is a serious regulatory notice that identifies specific infractions, mandates prompt corrective action, and signals the agency’s intent to pursue enforcement if the violations are not adequately and quickly addressed. It is a critical document in the regulatory oversight of the hormonal health and wellness space.