FDA 483 - 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, under the Federal Food, Drug and Cosmetic Act as amended by the Tobacco Control Act. While no FDA 483 was issued, the inspection revealed several concerns. The firm used claims like "100% real," "100% All Natural Tobacco," and "BEST TASTING NATURAL CIGARETTE" on its Aura brand cigarette labeling and point-of-sale advertising, despite management's awareness of related litigation. Additionally, Cheyenne International refused to provide full customer names for interstate commerce records, offering only city and state locations of its top ten customers, citing legal advice. Quality system deficiencies included a lack of independent verification for Certificates of Analysis for direct materials, no routine supplier audits, and no documentation of meetings with suppliers. The firm also failed to document temperature and humidity readings, and lacked written procedures for handling customer complaints, product recalls, and returned goods. Management was reminded of its ongoing responsibility for compliance with the FD&C Act, specifically regarding record access, and advised to address these procedural gaps and labeling practices.