Warning letter sent after dangerous mislabeling leads to recall

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

A food firm has received a warning letter for mislabeling. Mislabeling is a food safety concern because undeclared allergens and other labeling problems are a serious threat to public health and often result in large scale recalls.

Dole Fresh Vegetables, Inc.
Monterey, CA

In a Sept. 25 warning letter, the FDA informed officials with Dole Fresh Vegetables Inc. that they did not meet the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

 The warning was initiated based on a customer complaint. The customer said that three consumers reported that the incorrect masterpack was found in HEB brand Tuscan Herb Chopped Salad Kit. The firm then recalled the product. 

The firm indicated in their news release that the mislabeling occurred when “[t]he incorrect masterpack (kit with dressing and other toppings) was unintentionally used during the production of the salad.” The masterpack used held dressing that contained peanut butter and almond, cashew, and chow mein noodle (wheat) toppings.

The firm indicated that the cause was that they “did not have a robust enough verification process for product changeover.” 

The firm took the preventive actions of “Modification of Masterpack consumption form (redacted)” and “Implementation of Masterpack verification (redacted).” The FDA will verify the implementation of any corrective actions during their next inspection of the firm’s facility.

The full warning letter can be viewed here.

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