Warning letters sent because of dangerous mislabeling

Editor’s note: 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.

Two food firms have received warning letters for misbranding. Misbranding is a food safety concern because undeclared allergens and other labeling problems are a serious threat to public health.

Winter Gardens Quality Foods Inc.
New Oxford, PA

A company in Pennsylvania is on notice from the FDA for not declaring milk, a major food allergen, on Whole Foods brand Vodka Sauce’s finished product label. This was the result of a mistaken switching of product labels. 

In a Aug. 5 warning letter the FDA explains its inspectors determined that Winter Gardens Quality Foods Inc. did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule).

On March 20, after the firm was notified by a customer of a mislabeled product, the firm recalled the Whole Foods brand Vodka Sauce. The Vodka Sauce, which contains milk, was mislabeled with Puttanesca Sauce back panel ingredient labels that do not declare milk. 

The firm stated “the associate that was changing over the label machine did not properly check the new roll of labels.” On June 10 the company provided an updated “Procedure for Proper Packaging and Labeling,” and records of employee training as evidence of corrective actions taken by your firm. The FDA will verify implementation of any corrective actions during the next inspection of their facility.

The full warning letter can be viewed here.

Pero Family Farms Food Company LLC
Delray Beach, FL

A company in Florida is on notice from the FDA for not declaring egg and milk, major food allergens, on Zucchini Spiral Pesto Side Dish Kits finished product labels. This was the result of a mistaken switching of product labels.

In Aug. 5 warning letter the FDA explains that they have determined that Pero Family Farms Food Company, LLC did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule).

On March 10, after the firm was notified by a customer of a mislabeled product, the it recalled Zucchini Spiral Pesto Side Dish Kits. The Zucchini Spiral Pesto Side Dish Kits were mislabeled with a sweet teriyaki veggie rice back panel label that does not declare egg and milk ingredients. The firm provided corrective and preventive actions to the Office of Human and Animal Food Operations East Division 4 Recall Coordinator (DRC) by email on April 9 stating, “(redacted).” The FDA will verify implementation of any corrective actions during the FDA’s next inspection of your facility.

The full warning letter can be viewed here.

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