FDA WARNING_LETTER - Darbar Foods - April 03, 2020

On June 3, 2020, the FDA issued a Warning Letter to Ethnic Specialties, Inc. dba Darbar Foods, following Foreign Supplier Verification Program (FSVP) inspections on April 3, 2020, and August 23, 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.

The primary violation identified was the firm's failure to have FSVPs for imported Frozen Sheermal and Mezban Potato Samosa from (b)(4), constituting a significant violation of Section 805 of the FD&C Act. The firm also failed to respond to two Form FDA 483a, FSVP Observations, issued after both inspections.

The FDA emphasized that these violations are not exhaustive and that the firm is responsible for full compliance. Failure to promptly correct these issues 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) under Import Alert #99-41. Importing food without a compliant FSVP is prohibited under Section 301(zz) of the FD&C Act.

Ethnic Specialties, Inc. must respond in writing within fifteen working days, detailing corrective actions