FDA WARNING_LETTER - Metro Produce Distributors, Inc. - March 01, 2012

On February 24, 27, and March 1, 2012, the FDA inspected Metro Produce Distributors, Inc.'s facility in Minneapolis, Minnesota, and found violations of the Federal Food, Drug, and Cosmetic Act, specifically the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). These violations render their 100% orange, grapefruit, and tangerine juices adulterated under section 402(a)(4) of the Act.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 120.24(a)):** The HACCP plan lacks control measures to consistently achieve a 5-log reduction for pertinent microorganisms in grapefruit and tangerine juices. A submitted validation study for orange juice's surface treatment, also applied to grapefruit and tangerine, was deemed insufficient due to issues with EPA label verification, lack of stem-scar inoculation, unclear impact of washing/acidic solution, and insufficient data. 2. **Lack of Finished Product Testing (21 CFR 120.24, 21 CFR 120.25):** The firm does not analyze finished grapefruit and tangerine juices for biotype I *Escherichia coli*, which is required when relying on indirect treatment methods. 3. **Failure to Implement Monitoring Procedures (21 CFR 120.8(a