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FDA Inspections Target Two Juice Makers

Juice processing facilities in Indiana and Puerto Rico received warning letters recently from the Food and Drug Administration after failing inspections conducted last year.

Both a Feb. 23 warning letter to Goshen, IN-based Sunrise Orchards Inc., and a March 23 warning letter to Bayamon, PR-based Jonlly Fruits Inc. were made public on June 7 by FDA.

FDA said the Indiana company’s juice processing facility was inspected on multiple dates last October.  Among the “serious violations” FDA inspectors said they observed was a bin of damaged apples used to make the company’s cider.

In its Hazard Analysis and Critical Control Points (HACCP) plan, Sunrise says it will continuously monitor to ensure that “moldy, rotten, bruised or otherwise damaged fruit” will not be processed.


The juice maker is failing to monitor “conditions and practices” during processing, FDA said.  Among items observed during inspection were:

— Post-pasteurization piping connected to the surge tank with duct tape.

— Piping cleaned only by flushing it with water.

— Holes in the juice tank lid covered with duct tape.

— Pasteurized apple juice observed leaking from piping leading from the surge tank to the rotary filter and dripping on to the outer surfaces.

— A hole in the roof of the storage area filled with two torn bags of exposed rice hulls.

— Gaps around doors that allowed the entry of pests.

FDA said the company’s apple juice was not being held at refrigerated temperatures to “prevent the rapid growth of undesirable bacteria.”

The warning letter says Sunrise replied to FDA’s Form 483 report on the inspection on Jan. 19, but the response was not deemed to be sufficient because it lacked documentation.

The Puerto Rican fruit juice and fruit juice beverage processing facility was the subject of an inspection last Sept. 20 to Oct. 5.  Jonlly did not have a HACCP plan for its juice products, FDA said, and the inspection turned up other problems as well.

Among those problems:  mixing tanks in the production room did not have protective covers. Water was dripping into the orange drink from an overhead pipeline. When a knob from a water valve fell into a mixing tank, an employee reached into the tank and removed it.  

FDA said the employee was going to continue processing until a company consultant stopped him and persuaded the employee to drain and sanitize tank before using it again.

The facility also lacked hot water at suitable pressures and a second floor hand-washing sink did not have hot water, the warning letter stated.

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