FDA WARNING_LETTER - SeaSnax - February 25, 2020

On April 17, 2020, the FDA issued a Warning Letter to SeaSnax LLC following a Foreign Supplier Verification Program (FSVP) inspection on February 25, 2020, and a prior inspection on September 19, 2018. The inspections aimed to assess compliance with Section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L, which mandates importers perform risk-based activities to verify imported food meets U.S. safety standards.

SeaSnax LLC was found non-compliant for not having FSVPs for several imported products: SeaSnax - Original, SeaSnax - Grab & Go, and SeaSnax - Raw from one foreign supplier, and Chomperz Crunchy Seaweed Chips - Original from another. This violates 21 CFR 1.502(a). Form FDA 483a, FSVP Observations, was issued after both inspections, but no response was received.

The FDA stated that failure to promptly correct these violations could lead to further action, including refusal of admission for the specified products under Section 801(a)(3) of the FD&C Act, and placement on detention without physical examination (DWPE) via Import Alert #99-41. Importing food without a compliant FSVP is also prohibited under Section 301(