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Based on limited metadata available, Samson Pharmaceuticals, Inc. received an FDA Warning Letter on December 13, 2018, regarding compliance issues with a product classified outside standard pharmaceutical categories. Without access to the full letter text or specific subject line details, the precise nature of the violations cannot be determined from the available information. The issuing office is not specified in the metadata provided, limiting clarity on which FDA division oversaw this enforcement action. Additional documentation would be needed to identify the specific regulatory requirements that were not met.