FDA WARNING_LETTER - SCO Koladen LLC - December 07, 2021

On December 1-7, 2021, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of SCO Koladen LLC, following a previous inspection in June 2019. The inspection aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, which mandate risk-based activities for importers to ensure imported food meets U.S. safety standards.

The inspection revealed significant violations: SCO Koladen LLC failed to develop, maintain, and follow an FSVP for imported foods, including Milk Chocolate with Almonds, (b)(4), and Advent Calendar with chocolate pieces. While the company provided some supplier documents (a "FSMA" document, an Audit Report, and a Food Safety Plan), these were deemed incomplete and lacked evidence of the importer's review or application to an FSVP.

The FDA issued a Form FDA 483a FSVP Observations. SCO Koladen LLC's December 20, 2021, response, promising FSVP development by March 11, 2022, was deemed inadequate due to the lack of submitted FSVP records or further information.

Failure to address these violations may lead to refusal of admission for imported food under Section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99