Dream Wholesale, Inc – FDA Warning Letter, Aug 2, 2023

On February 15, 2024, the FDA issued a Warning Letter to Dream Wholesale, Inc. following a Foreign Supplier Verification Program (FSVP) inspection on May 16 and August 2, 2023, and previous inspections in 2020, 2021, and 2022. The inspection revealed significant violations of 21 CFR part 1, subpart L, and section 805 of the FD&C Act.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 1.504(b)(1)):** The company's hazard analyses for imported foods like soda water, cooked chickpeas, grape leaves, dried apricot paste, and frozen spinach did not specify biological, chemical, or physical hazards, only broad categories. 2. **Lack of Approved Foreign Supplier Procedures (21 CFR 1.506(a)(1)):** Dream Wholesale, Inc. failed to establish written procedures for approving foreign suppliers based on performance and risk, and could not provide records of supplier evaluations for various imported products. 3. **Failure to Perform Verification Activities (21 CFR 1.506):** The company did not document the determination or performance of appropriate supplier verification activities for multiple imported foods and lacked written procedures for these activities. 4. **Failure to Investigate Adulterated Products (21