FDA WARNING_LETTER - Green Day Produce, Inc. - February 12, 2024

On February 7-12, 2024, the FDA inspected Green Day Produce, Inc. for compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L). Previous inspections occurred on August 24, 2023, and February 9, 2023. The inspection revealed significant violations regarding imported seafood mushrooms, oyster mushrooms, and mangos, which are "covered produce" under the Produce Safety Rule (21 CFR part 112).

Specifically, Green Day Produce, Inc. failed to evaluate foreign suppliers' performance and food risk, including compliance with the Produce Safety Rule, as required by 21 CFR 1.505(a)(1)(iii). The provided "Produce Safety Rule and FSVP Standards" document was deemed insufficient, and the identified foreign suppliers (b)(4) and (b)(4) did not meet the definition of a foreign supplier.

Additionally, supplier verification activities did not adequately assure that hazards were minimized or prevented, violating 21 CFR 1.506(c). A third-party audit for oyster and seafood mushrooms did not assess compliance with the Produce Safety Rule. A "Food Safety Plan for Produce Supply Chain at Green Day Inc." was provided but lacked product or supplier specificity.

The FDA acknowledged the company's February 27, 2024, response but found it inadequate