FDA WARNING_LETTER - IMAD International, LLC - January 14, 2021

On March 29, 2021, the FDA issued a Warning Letter to IMAD International, LLC following remote Foreign Supplier Verification Program (FSVP) inspections on January 14, 2021, and April 18, 2019. The inspections found the company non-compliant with Section 805 of the FD&C Act and 21 CFR part 1 subpart L for imported honey beans, melon seeds, and plantain chips.

Significant violations include: 1. Failure to develop, maintain, and follow an FSVP for plantain chips (21 CFR 1.502(a)). 2. Failure to conduct a hazard analysis for melon seeds and honey beans (21 CFR 1.504(a)). 3. Failure to document approval of foreign suppliers for melon seeds and honey beans (21 CFR 1.505(b)). 4. Failure to establish and follow written procedures for importing only from approved foreign suppliers (21 CFR 1.506(a)(1)). 5. Failure to establish and follow written adequate procedures for conducting foreign supplier verification activities (21 CFR 1.506(b)). 6. Failure to conduct and document required supplier verification activities for melon seeds and honey beans (21 CFR 1.506(e)(1)).

The company