FDA WARNING_LETTER - Ricker Hill Farms, Inc. - September 09, 2017

The FDA inspected Ricker Hill Farms' apple cider facility from August 21 to September 9, 2017, finding serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120), rendering their apple cider adulterated.

A sample of "Ricker Hill Orchards Apple Cider" collected on August 31, 2017, showed a patulin level of 125 ppb, exceeding FDA's action level of 50 ppb. The firm conducted a voluntary recall of affected products.

Key HACCP deviations include: 1. Inadequate critical limit for patulin control in the HACCP plan. 2. Failure to maintain monitoring records for critical control points, with only one record provided for 2017 production. 3. Corrective actions in the HACCP plan that do not address the cause of deviations or ensure adulterated product does not enter commerce. 4. Failure to monitor conditions and practices with sufficient frequency to ensure GMP conformance, citing pitted flooring, damaged door frames, and discolored/ripped plastic strip curtains.

Additionally, labeling violations were noted: 1. Products like Apple Cider, Cran-Breeze, and others are adulterated because they use a food additive (b)(4) not approved for juice content exceeding 50%, and fail to declare this additive on labels. 2.