FDA WARNING_LETTER - Hood River Juice Company, Inc. - December 06, 2017

The FDA inspected a juice processing facility in Hood River, Oregon, from November 27 to December 6, 2017, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). These violations render the apple juice products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Significant violations include: 1. **Inadequate HACCP Plan for Patulin Control:** The HACCP plan failed to identify patulin as a reasonably likely food safety hazard, as required by 21 CFR 120.8(b)(1). While the hazard analysis identified patulin, it was addressed through an operational prerequisite program (oPRP) at the "Fruit Inspection and Sorting" step instead of a Critical Control Point (CCP). Evidence of inadequacy included damaged fruit on the conveyor after sorting and internal test results showing patulin levels above the 50 ppb action level (e.g., 187 ppb, 92 ppb, 67 ppb). The oPRP's operational limit of "(b)(4)% cull fruit per (b)(4) apples inspected" was deemed insufficient, and apples stored outdoors without controls increased patulin formation risk. The firm's December 18, 2017, response indicated an intent to revise the hazard assessment and reassign the o