FDA WARNING_LETTER - Transworld International Trading Corp. - February 18, 2022

On July 5, 2022, the FDA issued a Warning Letter to Transworld International Trading Corp. following inspections on January 13-February 18, 2022, and October 24, 2019. The inspections assessed compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1 subpart L) for imported human and animal food.

The FDA found significant violations, including the failure to develop, maintain, and follow an FSVP for various imported foods such as (b)(4) from (b)(4), (b)(4) chocolate from (b)(4), and (b)(4) chocolate from (b)(4). For puffed snacks botanas (tortilla chips) from (b)(4), the company failed to determine and document the frequency of required verification activities (21 CFR 1.506(d)). Additionally, Transworld International Trading Corp. did not perform adequate foreign supplier verification activities (21 CFR 1.506(e)), specifically failing to review and assess a recent third-party audit report for the tortilla chips and providing audit reports that did not confirm compliance with FDA food safety regulations.

The FDA noted that no response to the Form FDA 483a issued on February 18, 2022, had been received. Failure to address these violations may result in refusal of admission for imported food