The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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. Big Island Candies Inc. Hilo, HI A food firm in Hawaii is on notice from the U.
S. Food and Drug Administration (FDA) for violations of the Federal Food, Drug, and Cosmetic Act. In a May 29 warning letter, the FDA described Big Island Candies Inc.
’s Jan. 10 recall of Big Island Candies Makana Brownie Assortment Box after the firm discovered the box contained Milk Chocolate Covered Peanut Butter Brownies instead of Milk Chocolate Covered Macadamia Nut Brownies. The printed label on the assortment box did not contain an allergen statement or ingredient declaration for peanuts.
The firm became aware of the undeclared peanut after a consumer notified them that they experienced an allergic reaction to peanuts after consuming a brownie packed from the assortment box of Makana brownies. In documentation provided to the Office of Human and Animal Food Operations West Division 5 Recall Coordinator on Jan. 15, the firm indicated that Milk Chocolate Covered Peanut Butter brownies were unintentionally packed into the assortment box, which was labeled to contain brownies containing macadamia nuts.
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