Transphere, Inc.

Warning LetterOpen

Eugene Potemkin Chief Executive Officer Transphere, Inc. 261 Robbyn Lane Oceanside , NY 11572 United States transpherenyc@gmail.comIssued Mar 28, 2022Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations0

Issue DateMar 28, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: Transphere, Inc.
Location: Eugene Potemkin Chief Executive Officer Transphere, Inc. 261 Robbyn Lane Oceanside , NY 11572 United States transpherenyc@gmail.com
FEI Number: N/A
Country: United States
Issue Date: March 28, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

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.

Transphere, Inc. FDA Warning Letter, March 28, 2022