“Serious deviations” from federal food safety regulations, including juice Hazard Analysis and Critical Control Point (HACCP) rules, were reported in a Feb. 4 warning letter to Chicago’s Juice Tyme Inc.
The U.S. Food and Drug Administration (FDA) says the Premium Orange 4 + 1 with Pulp juice product made by Juice Tyme is adulterated “in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.”
Juice Tyme makes stable, bag-in-box beverages for sale in bars and restaurants, school cafeterias, and numerous other food service outlets.
Juice Tyme’s juice processing facility at 4401 South Oakley in Chicago was subjected to FDA inspection last July 20 through Sept. 30. FDA said the inspection turned up “serious deviations” from the regulations. For example:
— Its HACCP plan for Premium 4 + 1 with Pulp fails to list measures that will achieve a 5-log reduction on pertinent microorganisms.
A “5-log reduction” means lowering the number of microorganisms by 100,000-fold, that is, if a surface has 100,000 pathogenic microbes on it, a 5-log reduction would reduce the number of microorganisms to one.
“According to your October 13, 2010 response, your firm indicates that Juice Tyme, Inc. is currently in the advance stages of installing a pasteurization system that would perform the necessary 5-log reduction of microorganisms of this product,” the warning letter says. “However, as mentioned above, the “Premium Orange 4 + 1 with Pulp” you currently market and manufacture requires a 5-log reduction and the study you provided to FDA does not ensure the safety of the “Premium Orange 4 + 1 with Pulp”. Your documentation failed to identify the critical factors that result in a 5-log reduction and failed to document that the process you are using is identical to the conditions in the study provided.”
FDA also Juice Tyme was failing to monitor the condition and cleanliness of food contact surfaces, prevent cross contamination, and protect food, food packaging materials and food contact surfaces from pests.
— Inspectors reported seeing “fly-like” insects in the process and packaging areas, blending room, and in lemon juice concentrate.
FDA said as a manufacturer of acidified food products, Juice Tyme must obtain an emergency control permit. Inspectors found documented deviations from the acidified food law involving thickened water nectar, thickened water lemon, and thickened water honey. The deviations mean Juice Tyme’s acidified food products are adulterated.
FDA said the juice maker failed to file a scheduled process for its thickened water products. It also failed to register as a commercial processor of acidified foods. That should have been done within 10 days of the startup of a manufacturing.
Juice Tyme also failed to use a qualified person on the project who would have known how to schedule processes for the thickened water products. It also failed to do the testing and recording required to control pH levels.
Juice Tyme did not respond to Food Safety News with a comment on the warning letter. On its website, the juice maker says it takes “the lead when it comes to food safety and manufacturing practices–from product testing to blending to packaging.”