FDA WARNING_LETTER - Juice Pac Inc - May 06, 2010

On May 4-6, 2010, the FDA inspected Juice Pac, Inc.'s facility in Bowling Green, KY, and found serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). The firm manufactures 100% juice concentrate products, which are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. Failure to perform a 5-log pathogen reduction for Drink Bases (100% Juice with other added ingredients), as required by 21 CFR 120.24(a), (b), and (c). 2. The HACCP plan for Drink Bases does not list pasteurization as a critical control point for pathogen control, violating 21 CFR 120.8(b)(2). 3. Failure to maintain sanitation control records for various critical areas, including food contact surfaces, cross-contamination prevention, handwashing, and employee health, as required by 21 CFR 120.6(c).

The FDA reviewed the firm's May 12 and May 17, 2010, responses to the FDA-483 observations and clarified that Juice Pac does not meet the 5-log reduction standard by relying on supplier