The Carrizozo Orchard – FDA Warning Letter, Oct 19, 2012

On October 17 and 19, 2012, the FDA inspected Carrizozo Orchard's juice processing facility, identifying serious deviations from juice Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 120) and Current Good Manufacturing Practice (GMP) regulations (21 CFR Part 110). The unpasteurized 100% apple cider products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to insanitary conditions.

Key violations included: 1. Failure to implement a 5-log reduction process for pertinent microorganisms in 100% apple cider, as required by 21 CFR 120.24(a) and (c). The firm repackaged cider without this process. 2. Absence of a written HACCP plan for 100% apple cider to control food safety hazards, violating 21 CFR 120.8(a). 3. Failure to develop a written Hazard Analysis for 100% apple cider to identify and control food safety hazards, as per 21 CFR 120.7(a). 4. Lack of a Sanitation Standard Operating Procedure (SSOP) addressing sanitation conditions and practices, and inadequate sanitation control records, violating 21 CFR 120.