FDA WARNING_LETTER - Fatima Brothers - February 13, 2020

On April 7, 2020, the FDA issued a Warning Letter to Fatima Brothers Inc. following a Foreign Supplier Verification Program (FSVP) inspection on February 13, 2020, and an initial inspection on July 25, 2018. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandates importers to conduct risk-based activities to verify imported food meets U.S. safety standards.

The firm was found non-compliant for not developing FSVPs for specific imported foods: (b)(4) Boiled Rice from (b)(4), (b)(4) from (b)(4), and (b)(4) (Cake rusk) from (b)(4). These significant violations mean the firm is not in compliance with Section 805 of the FD&C Act. The FDA investigator issued Form FDA 483a, FSVP Observations, after both inspections, but no response was received.

Failure to correct these violations may lead to further action, including refusal of admission for the listed products under Section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert #99-41. Importing food without a compliant FSVP is also prohibited under Section 301(zz) of the