Transphere, Inc. Warning Letter Details

Summary

Transphere, Inc., a domestic importer of cigarettes, cigars, and roll-your-own tobacco, failed to remit required user fee assessments to the FDA as mandated under Section 919 of the Federal Food, Drug, and Cosmetic Act by the quarterly deadlines. Due to this non-payment of assessed user fees, the FDA determined that all regulated tobacco products imported by the company were adulterated under Section 902(4) of the FD&C Act. The company had been assessed user fees by FDA's Office of Financial Management but had not made payment on the invoices issued to it.