NASCO Products LLC – FDA EIR, Oct 21, 2015

An FDA surveillance inspection of NASCO Products LLC, a tobacco manufacturer in Mocksville, NC, took place on October 21, 2015. Operating under the Federal Food, Drug and Cosmetic Act as amended by The Tobacco Control Act, the inspection revealed several procedural and documentation deficiencies. Key issues identified included the absence of a formal, documented employee training program, and a lack of written employee responsibilities. The company also demonstrated incomplete incoming material acceptance activities, such as inconsistent quality control testing, no unique product identifiers, and a general lack of supplier audits or comprehensive material specifications. Production quality checks, including visual inspections and specific tests for finished cigarettes, were not consistently documented. Additionally, there was no documented rework procedure, complaint log, or established corrective and preventive action (CAPA) program, and recall procedures were not in place. A significant finding was the firm's inability to provide evidence of commercial marketing for eleven Smoker’s Friendly products to substantiate their grandfathered status. Management was formally reminded of their ongoing responsibility for regulatory compliance. As a voluntary correction, NASCO Products LLC removed a promotional graphic from its social media implying reduced harm, and committed to updating its product listing and outdated operations manual to reflect current practices.