FDA 483 - Sherman's 1400 Broadway, N.Y.C. Ltd. - February 11, 2015

A comprehensive surveillance inspection of Sherman's 1400 Broadway, N.Y.C. Ltd., a tobacco manufacturer located in Greensboro, NC, was conducted by the FDA on February 10-11, 2015. The inspection covered the firm's receiving, manufacturing, packaging, labeling, and distribution operations, along with a review of relevant documentation. Notably, no objectionable conditions were identified during this inspection, and consequently, an FDA Form 483, Inspectional Observations, was not issued. The firm is registered under the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. While this inspection found no issues, a previous inspection in April 2013 had cited the firm for labeling various cigarette brands with "100% Natural Tobacco," a concern that management had not committed to correcting at that time. For the current inspection, management was reminded of their ongoing responsibility to comply with the FD&C Act and the potential penalties for non-compliance. No specific regulatory actions were required as a result of this inspection.