# FDA WARNING_LETTER - South Florida Import & Export Corp - July 27, 2021

Source: https://www.keypedia.com/records/warning_letter/south-florida-import-export-corp/084cd247-b29a-484c-bf0f-591e0e7923bd

> FDA WARNING_LETTER for South Florida Import & Export Corp on July 27, 2021. Product: Tobacco. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: South Florida Import & Export Corp
- Inspection Date: 2021-07-27
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On June 8, 2021, the FDA issued a Warning Letter to South Florida Import & Export Corp, identifying it as a domestic importer of cigars and roll-your-own tobacco products subject to user fees under section 919 of the FD&C Act. The core violation is the failure 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 non-payment renders all regulated tobacco products imported by the company adulterated under section 902(4) of the FD&C Act. The letter specifies that the FDA's Office of Financial Management (OFM) assessed user fees, but payment has not been received for enumerated invoices.

As a consequence, the introduction or delivery into interstate commerce of these adulterated tobacco products is a prohibited act under section 301(a) of the FD&C Act. Furthermore, the FDA will be unable to issue substantial equivalence (SE) orders for new tobacco products until all assessed fees are paid in their entirety, even if a repayment plan is in place.

The FDA requires a written response within 15 working days detailing corrective actions, including documentation of fee payment or contact with OFM to arrange payment, steps to prevent future violations, and a timetable for implementation if corrections are ongoing. Failure to address this may result in regulatory actions such as civil money penalties, seizure,

## Related Officers

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

Company: https://www.keypedia.com/companies/south-florida-import-export-corp/03052564-9b4f-4081-92e1-589b4d4b429d

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