FDA WARNING_LETTER - Knott's Wholesale Foods, Inc. - March 10, 2010

On March 9 and 10, 2010, an FDA inspection of Knott's Wholesale Foods, Inc. revealed significant violations regarding their "Pickled Eggs" product. The product was found to be adulterated under Section 402(a)(4) and misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act).

The "Pickled Eggs" product is an acidified food, requiring compliance with 21 CFR 108 (Emergency Permit Control) and 21 CFR 114 (Acidified Foods).

Key violations include: 1. **Misbranding:** The "Pickled Eggs" label fails to bear nutrition information as required by 21 CFR 101.9, and the firm is not exempt. 2. **Adulteration:** The firm failed to provide FDA with scheduled process information (Form FDA 2541a) for the "Pickled Eggs" product for each container size, as required by 21 CFR 108.25(c)(2). This is a repeat deviation.

The FDA also commented that if citric acid, salt, sodium benzoate, and potassium sorbate are present in significant amounts, they must be listed in the ingredient statement. If sodium benzoate and/or potassium sorbate function as preservatives, their function must be declared per 21 CFR 101.