FDA WARNING_LETTER - WANABANA USA LLC - March 07, 2024

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