FDA WARNING_LETTER - Sunrise Distributors Inc - December 05, 2019

On December 5, 2019, the FDA conducted a follow-up Foreign Supplier Verification Program (FSVP) inspection at Sunrise Distributors Inc., 2411 United Lane, Elk Grove Village, IL, following an initial inspection on July 9, 2018. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities to verify imported food meets U.S. safety standards.

The FDA found Sunrise Distributors Inc. was not in compliance, specifically lacking FSVPs for (b)(4) imported from (b)(4), fried onions imported from (b)(4), and basmati rice imported from (b)(4). This constitutes a significant violation of section 805 of the FD&C Act and 21 CFR 1.502(a), as the firm failed to develop, maintain, and follow an FSVP for these products.

The firm received Form FDA 483a, FSVP Observations, after both inspections but has not submitted a response. Failure to promptly correct these violations may lead to further action, including refusal of admission for the implicated products under section 801(a)(3) of the FD&C Act, and potential placement on detention without physical examination (DWPE) via Import Alert #99-41. Importing food without a compliant