FDA WARNING_LETTER - Banjaras Inc - July 10, 2019

On September 24, 2019, the FDA issued a Warning Letter to Ms. Kaur following FSVP inspections on August 21, 2017, and July 10, 2019, at 2702 Galion Dr., Sugar Land, TX. The inspections assessed compliance with Section 805 of the 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.

The firm was found non-compliant for not developing Foreign Supplier Verification Programs (FSVPs) for coriander and garlic and Rasam powders from foreign supplier (b)(4), Kesar mango pulp from foreign supplier (b)(4), and Suji rusk from foreign supplier (b)(4). These omissions constitute significant violations of Section 805 of the FD&C Act.

The FDA investigator issued a Form FDA 483a, FSVP Observations, but no response was received. The letter emphasizes that 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 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 FD&