Following inspections, the Food and Drug Administration issued warning letters that were recently made public to a Florida juice producer and a Hawaii company that produces tuna sandwiches.

Companies have 15 days to respond to FDA warning letters in writing. FDA has not yet issued a closeout letter for either of the companies listed below.

Florida Key West Inc., Lakeland, FL.
Florida Key West Inc, juice products
In a Dec. 22, 2016, warning letter to majority partner and president, Cappie Hose, the FDA cited “significant deviations from the Juice Hazard Analysis and Critical Control Point (HACCP) regulation” in the Federal Code. An FDA inspection Aug. 31 to Sept. 12, 2016, revealed the problems.

“… your firm does not have written hazard analyses or written HACCP plan or plans for your reconstituted 100 percent lemon juice and lime juice products to control microorganisms,” according to the warning letter.

The company, which according to its website produces “original, authentic key lime juice” as well as key lemon juice, lemon and lime juice from concentrate, specialty marinades, and cocktail mixers, responded to inspectors’ concerns Oct. 12, 2016. However, the FDA did not find the response adequate because Florida Key West Inc. is relying on foreign suppliers to take care of food safety issues.

“Although your response included HACCP documentation from your foreign lemon and lime juice concentrate suppliers, your firm meets the definition of a processor and is subject to the juice HACCP regulation,” FDA’s warning letter states.

“Consequently, you cannot rely on the HACCP documentations from your suppliers to satisfy the HACCP requirements specific to your processing operation.”

Hawaiian Ono Services Inc., Honolulu
In a Jan. 10 warning letter to owner and president, Sung Cha Ku, the FDA cited “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation” in the Federal Code. An FDA inspection on dec. 8-9, 2016, revealed the problems.

“… your refrigerated ready-to-eat tuna salad sandwiches, containing cooked tuna, are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” according to the warning letter.

Violations included failure to have a HACCP plan to “control the food safety hazards of histamine, pathogen growth, allergens and metal inclusion;” employees’ failure to follow proper hygiene practices while handling food with their bare hands; and using a sanitizer solution that didn’t have any sanitizer in it.

“Similar observations of poor employee hygienic practices have been made during our previous inspections of your facility,” the warning letter states.

“We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.”

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