# FDA WARNING_LETTER - SCO Koladen LLC - December 07, 2021

Source: https://www.keypedia.com/records/warning_letter/sco-koladen-llc/d80e67c7-70ff-4c3d-9056-3f067293d883

> FDA WARNING_LETTER for SCO Koladen LLC on December 07, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: SCO Koladen LLC
- Inspection Date: 2021-12-07
- Product Type: Food
- Office Name: Division of West Coast Imports Compliance Branch
- Summary: 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

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/kathleen-turner/bad9bf93-dd82-438b-88cb-887a2416dd68)

Company: https://www.keypedia.com/companies/sco-koladen-llc/f6355663-3725-4380-add0-bdb9889ad3c9

Office: https://www.keypedia.com/offices/division-of-west-coast-imports-compliance-branch/c2ac6680-0cab-4f7f-83ac-1c2b18073c50