# FDA WARNING_LETTER - GSM Services, LLC - May 30, 2023

Source: https://www.keypedia.com/records/warning_letter/gsm-services-llc/f07f5a1b-4847-4b77-a44e-cbe9dc06fe40

> FDA WARNING_LETTER for GSM Services, LLC on May 30, 2023. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: GSM Services, LLC
- Inspection Date: 2023-05-30
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On May 17, 2023, the FDA issued Warning Letter 7533 to GSM Services, LLC., a domestic importer of pipe tobacco, cigars, and roll-your-own tobacco products. The FDA determined that GSM Services, LLC. failed to pay user fees assessed under section 919 of the FD&C Act (21 U.S.C. § 387s). Specifically, the company has outstanding user fee payments for multiple fiscal quarters from 2019 through 2022, with assessment invoice dates ranging from March 1, 2019, to December 1, 2022.

As a result of the failure to pay assessed user fees, all regulated tobacco products imported by GSM Services, LLC. are deemed adulterated under section 902(4) of the FD&C Act (21 U.S.C. § 387b(4)). The introduction or delivery into interstate commerce of adulterated tobacco products is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). Furthermore, the FDA will be unable to issue substantial equivalence orders for new tobacco products until all assessed fees are paid in their entirety, even if a repayment plan is established.

GSM Services, LLC. is required to submit a written response within

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.keypedia.com/companies/gsm-services-llc/f12f3384-d96c-4193-8659-6b24fa49d3ae

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374