# FDA WARNING_LETTER - Paramount Imports LLC - January 26, 2021

Source: https://www.keypedia.com/records/warning_letter/paramount-imports-llc/43e9686a-832f-4b70-99ff-0ec7cad3fce5

> FDA WARNING_LETTER for Paramount Imports LLC on January 26, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Paramount Imports LLC
- Inspection Date: 2021-01-26
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On September 1, 2020, the FDA issued a Warning Letter to Paramount Imports LLC, identifying them as a domestic importer of cigars subject to user fees under section 919 of the FD&C Act. The letter states that Paramount Imports LLC failed to pay assessed user fees by the last day of the applicable quarter, as required by section 919(b)(6) of the FD&C Act.

This failure to pay user fees renders all regulated tobacco products imported by Paramount Imports LLC adulterated under section 902(4) of the FD&C Act. The introduction or delivery into interstate commerce of adulterated tobacco products is a prohibited act under section 301(a) of the FD&C Act. Furthermore, the FDA will be unable to issue an order finding a new tobacco product described in a pending or future Substantial Equivalence (SE) Report to be substantially equivalent until all assessed fees are paid. Entering a repayment plan does not negate the adulterated status of the products.

Paramount Imports LLC is required to immediately correct these violations and submit a written response within 15 working days. The response must include documentation of user fee payment or contact with OFM to set up a payment plan, and steps taken to prevent future violations, including a timetable for implementation if corrections are ongoing. Failure to comply may result in further FDA action, including civil money penalties, criminal prosecution, seizure, and/or injunction.

## Related Officers

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

Company: https://www.keypedia.com/companies/paramount-imports-llc/0437177e-0e53-4491-8ba3-f7a2fce4a962

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