Is Ricker Hill Farms Safe? FDA Warning Letter Review (2018)

Detailed Analysis

False Claims and Regulatory Violations

1.    Your HACCP plan must, at a minimum, list the critical limits that must be met at each critical control point, to comply with 21 CFR 120.8(b)(3). A “critical limit” is defined in 21 CFR 120.3(e) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.” However, your firm's HACCP plan for "Ricker Hill Orchards Apple Cider" lists a critical limit of,(b)(4)at the "(b)(4)" critical control point. This critical limit is not adequate to control the patulin hazard. FDA recommends that you perform a root cause analysis to determine the source of high patulin levels in your apple juice, implement additional critical

This letter may not list all the deviations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and the juice HACCP regulation (21 CFR Part 120). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Potential Health Risks

The U.S. Food & Drug Administration (FDA) inspected your apple cider processing facility, located at 11 Ricker Hill Road, Turner, ME 04282, between August 21st, 2017 and September 9th, 2017. We found that you have serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR Part 120, or otherwise to operate in accordance with the requirements of Part 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your apple cider is adulterated i

Patulin is a toxic substance produced by molds that may grow on apples. FDA established an action level for patulin in apple juice of 50 ppb as determined on single strength apple juice or reconstituted single strength apple juice. An action level is a guideline that FDA uses in considering whether the level of contaminant in a food may constitute a health hazard sufficient to warrant regulatory action by FDA against the product. See FDA’s Compliance Policy Guide (CPG Section 510.150) concerning patulin for additional information:https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074427.htm

Regulatory Context

During the inspection, FDA collected sample 1003993 of “Ricker Hill Orchards Apple Cider” manufactured at your facility on August 31, 2017. Analysis revealed patulin level at 125 parts per billion (ppb). As evidenced by this sample result, your apple cider, represented by sample 1003993, is adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(1)].

Additionally, during the inspection of your firm we found the following significant deviations from the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 120:

2.    Your firm failed to maintain records documenting the monitoring of critical control points and their critical limits as required by 21 CFR 120.12(a)(4)(i). Specifically, your HACCP plan for “Ricker Hill Orchards Apple Cider” lists “(b)(4)” will be conducted on “(b)(4)” via “(b)(4)” at the “(b)(4)” critical control point and the results will be recorded on a “(b)(4)log.” However, you were unable to provide(b)(4)monitoring records for most of your 2017 production, with the exception of one record dated, August 26, 2017.