Hood River Juice Company Inc. in Hood River, OR, was inspected by the U.S. Food and Drug Administration Nov. 27 through Dec. 6 2017, 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. Hood River Juice Company responded on Dec. 18, 2017, saying it had updated its HACCP. However, the warning letter says the response was not adequate.

One of the most severe violations by the firm includes the failure to list all food safety hazards that are reasonably likely to occur, and specifically, their HACCP plan does not identify the food hazard of patulin.

The National Institutes of Health says patulin is a mycotoxin, found as a contaminant of foods, and it is commonly found in rotting apples. A number of studies have shown that it is genotoxic, which has led to some theories that it may be a carcinogen. Several countries have instituted patulin restrictions in apple products. Additionally, the World Health Organization recommends a maximum concentration of 50 micrograms/liter in apple juice.

According to the warning letter, FDA investigators observed damaged fruit on the conveyer line after the inspection and sorting, and the firm’s patulin test results indicated levels above 50 parts per billion (ppb). According to the FDA, “Any apples which are rotten, moldy, bruised or damaged should be trimmed or culled from production.”

“FDA recommends you perform a root cause analysis to determine the source of high patulin levels in your apple juice, and implement appropriate CCPs in your HACCP plan accordingly.”

Additional violations observed at Hood River Juice Company were:

  • Apples were found stored outside for extended periods without atmospheric or temperature controls in open, wooden bins; Such storage conditions increase the probability of patulin formation, thus resulting in elevated levels of patulin in the finished product.
  • Failure to monitor for the condition and cleanliness of food contact surfaces and the prevention of cross-contamination from insanitary objects; “Clumps of apple mash on mesh press bags after cleaning, prior to re-use,” and “Peeling paint with apparent black, mold-like growth on the ceiling above press bags.”
  • The FDA noted the firm’s practice of blending batches of apple juice which their internal testing found contained patulin above 50 ppb with batches of apple juice with patulin less than 50 ppb, to lower the patulin levels in the finished blends; “the FDA considers the deliberate mixing of adulterated food with good food renders the finished product adulterated under the Federal Food, Drug, and Cosmetic Act, regardless of the final concentration of contaminant in the finished product.”
  • 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.

“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 Hood River Juice Company to respond within 15 days to the April 25 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 Oregon State Department of Agriculture’s Food Safety Program.

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