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Custom Vapors Inc, operating as VIP Custom Vapors and Premier Vape, manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquid products, classified as tobacco products under the Family Smoking Prevention and Tobacco Control Act, were deemed subject to FDA regulation as of August 8, 2016, and required marketing authorization orders before commercial distribution. The inspection and submission review revealed that the company failed to secure this mandatory premarket approval before offering its products for sale in the United States.