FDA WARNING_LETTER - Milky Way International Trading Corporation - November 17, 2022

On April 14, 2023, the FDA issued a Warning Letter to Milky Way International Trading Corporation following a Foreign Supplier Verification Program (FSVP) inspection on November 4 and 17, 2022. Previous FSVP inspections were conducted in 2017 and 2020. The inspection revealed non-compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, for various imported foods, including Strawberry Syrup and Blueberry Syrup from (b)(4), and Canned Coconut Cream from (b)(4).

Key violations include: 1. Failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). 2. Failure to perform foreign supplier verification activities in accordance with 21 CFR 1.506. Specifically, the company did not determine and document the frequency of verification activities (21 CFR 1.506(d)(1)(i)). 3. Reliance on a third-party audit (by (b)(4)) for Strawberry Syrup and Blueberry Syrup that did not indicate consideration of applicable FDA food safety regulations (21 CFR 1.506(e)(1)(i)(B)). 4. No indication of review or assessment of audit results by a qualified individual (21 CFR 1.50