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Warning Letter says juice maker fails to pass FDA inspection

Stoney Ridge Farm LLC in Everson, WA, was inspected by the U.S. Food and Drug Administration Dec. 21 and 22, 2016, and again on Jan. 5 this year and the results were not good.

“The inspection revealed serious deviations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120,” FDA’s Seattle district director said in a Warning Letter to the juice processor.

After the inspections, an FDA Form 483, listing the deviations was left with the company. Stoney Ridge responded on Jan. 19, 2017, saying it had updated its HACCP. However, the Warning Letter says the response was not adequate.

Among the violations at Stoney Ridge are:

  • FDA WarningFailure to document the monitoring of critical control points by not recording actual times and temperatures and other measurements described in the HACCP plan.
  • Failure to document continuous recording thermometer and flow rate for apple cider in order to ensure control of biological hazards identified in HACCP plan.
  • Failure to monitor conditions and practices during processing with sufficient frequency to ensure conformance with current Good Manufacturing Practice regulations. This included failure to monitor the condition and cleanliness of food contact surfaces, protection of food, food packaging material and food contact surfaces from adulertion.
  • Failure to exclude pests from inside the juice facility. This is due to accumulated debris and flies in the production room.
  • Failure to maintain sanitation control records.

“You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur,” Miriam R. Burbach, FDA’s Seattle district director wrote. “These actions include, but are not limited to, an injunction.”

FDA asked Stoney Ridge Farm to respond within 15 days to the April 18 Warning Letter with specifics about how it plans to correct the deviations. “If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.”

A copy of the Warning Letter was sent by FDA to the Washington State Department of Agriculture’s Food Safety Program.


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