FDA EIR - Cheyenne International, LLC - June 07, 2016

An FDA surveillance inspection of Cheyenne International, LLC, a tobacco manufacturing firm in Grover, NC, was conducted from June 6-7, 2016. The inspection, operating under the regulatory framework of the FD&C Act as amended by the Tobacco Control Act, aimed to review the company's manufacturing, labeling, and distribution practices for various tobacco products. Significantly, the inspection concluded with "no objectionable conditions noted," and a formal FDA Form 483, Inspectional Observations, was not issued.

However, several areas were identified and discussed with management. These included specific labeling and point-of-sale advertising claims for Aura brand cigarettes, such as "100% real" and "100% All Natural Tobacco," which were documented, with management acknowledging ongoing litigation concerning such statements. The firm also refused to provide specific customer names for interstate commerce records, offering only city and state locations for its top ten customers. Further observations noted the absence of documented written procedures for handling customer complaints, product recalls, and processes for damaged product returns. Additionally, the firm lacked routine, formal supplier audits and independent verification of Certificates of Analysis for direct materials. While temperature and humidity were monitored, the readings were not documented. Management was reminded of their ongoing responsibility for regulatory compliance.