FDA EIR - US Smokeless Tobacco Products LPF - February 06, 2018

U.S. Smokeless Tobacco Products, LLC - LPF underwent an FDA inspection on February 6, 2018, in Richmond, VA. The inspection, conducted under the Federal Food, Drug, and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act, focused on the firm's manufacturing of newly deemed nicotine delivery products, specifically Verve brand discs and chews. A key finding was the clarification that the facility operates as both a research and product development center and an active manufacturer of these commercially marketed nicotine delivery products, contrary to a previous inspection report that noted it solely as an R&D facility. Importantly, the inspection concluded without identifying any deficiencies, and a Form FDA 483 (Inspectional Observations) was not issued. The review encompassed a thorough examination of the firm's manufacturing operations and quality systems, including batch records, work instructions, in-process and finished product quality checks, laboratory analysis, packaging verification, incoming material acceptance, equipment cleaning, employee training, and hazard analysis. Given the absence of observed deficiencies, no specific corrective actions were required from the company as a direct result of this inspection.