FDA WARNING_LETTER - Big Vegetarian Supply Inc. - March 22, 2024

On September 26, 2024, the FDA issued a Warning Letter to Big Vegetarian Supply, Inc. following a Foreign Supplier Verification Program (FSVP) inspection on March 22, 2024. Previous inspections occurred on March 19, 2020, and May 13, 2022. The inspection aimed to assess 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 FDA acknowledged the company's responses dated April 5, 2024, and June 7, 2024, where a consultant stated they would develop FSVP Plans and provide training. The June 7 response included documentation indicating the company qualifies as a "very small importer" under 21 CFR 1.500 and 1.512, with annual average sales and imported food value below $1 million for 2021-2023. The response also included an FSVP for a foreign supplier, a written assurance, a HACCP plan, and lab reports.

Despite this, significant FSVP violations were identified for imported products: Frozen (b)(4) from (b)(4), Imitation Chicken (b)(4) from (b)(4), and Chewy Candy