FDA WARNING_LETTER - Island Desserts LLC - June 30, 2011

The FDA inspected Island Desserts LLC (operating as Pastry Art) in Walpole, Massachusetts, from June 16-30, 2011, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key CGMP violations included failure to protect work-in-process from contamination (21 CFR 110.80(b)(5)), specifically regarding allergen cross-contact. Examples cited were placing non-nut products on trays with nuts, slicing nut and non-nut products without glove changes, and storing uncovered nut-containing foods next to or above uncovered non-nut foods. The firm's July 8, 2011, response to the FDA 483 was deemed inadequate due to a lack of detailed corrective actions, such as specific segregation plans, wash-down procedures, and employee training details. The FDA also noted that precautionary labeling is not a substitute for CGMP adherence. Additionally, employees were observed wearing torn gloves during food production, violating 21 CFR 110.10(b)(5).

Furthermore, the Chocolate Cherry Biscotti and Traditional Almond Biscotti products were found to be misbranded under Section 403 of the Act. Violations included failure to declare major food