# FDA WARNING_LETTER - WANABANA USA LLC - March 07, 2024

Source: https://www.keypedia.com/records/warning_letter/wanabana-usa-llc/43185eab-4e7c-42bf-adfe-405b94a832b9

> FDA WARNING_LETTER for WANABANA USA LLC on March 07, 2024. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: WANABANA USA LLC
- Inspection Date: 2024-03-07
- Product Type: Food
- Office Name: Division of Southeast Imports
- Summary: On November 4, 2024, the FDA issued a Warning Letter to WanaBana USA LLC following an FSVP inspection from February 21 to March 7, 2024. The inspection, initiated due to a multistate investigation of elevated lead levels in apple cinnamon fruit puree pouches, found the firm non-compliant with 21 CFR part 1, subpart L, and section 805 of the FD&C Act.

The primary violations include:
1.  **Failure to conduct a proper hazard analysis (21 CFR 1.504(a)):** The firm's hazard analysis for fruit purees and smoothies from foreign supplier Austrofood S.A.S. did not identify or evaluate heavy metals, specifically lead, as a potential chemical hazard requiring control. This omission occurred despite the product being subject to a Class 1 recall due to extremely high lead concentrations (e.g., 2.18 ppm, 6.43 ppm, 2.16-3.19 ppm).
2.  **Inadequate foreign supplier verification activities (21 CFR 1.506(c), (e)):** The firm did not conduct and document required supplier verification activities, such as a 2022 audit, before importing the apple cinnamon puree. Additionally, a provided Quality Certificate for cinnamon testing lacked required details like analytical methods, test dates, or

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/ruth-p-dixon/9c1382c8-baa0-4f06-a7d3-151e54eaebbc)

Company: https://www.keypedia.com/companies/wanabana-usa-llc/01bbcf22-e68a-4bb7-aa18-01675d6af405

Office: https://www.keypedia.com/offices/division-of-southeast-imports/919f1cd1-7774-46f7-b8ec-18c4a31f1024