FDA WARNING_LETTER - Tiller Biscotti & Cookie Company - September 29, 2010

On September 14-15 and 29, 2010, an FDA investigator inspected Tiller Biscotti & Cookie Company's biscotti manufacturing facility in Jackson, Mississippi. The inspection revealed serious deviations from 21 CFR Part 110, Current Good Manufacturing Practice (CGMP) for Human Food, rendering their products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, the labeling for their almond biscotti product was found to be misbranded under Section 403 of the Act.

Violations included: 1. Failure to prevent cross-contamination: Almond biscotti (containing tree nuts) was manufactured on the same equipment as chocolate cube biscotti (nut-free) without cleaning in between. The owner handled non-sanitized objects and continued preparing raw product without washing hands. 2. Eating and drinking in food preparation areas. 3. Food production employees (the owner) not wearing beard covers or hair restraints. 4. Failure to maintain food processing equipment and utensils to prevent contamination: A mixing bowl was placed on the floor and then on an unwashed wooden table used for preparation. 5. Failure to clean non-food-contact surfaces: A dusty return air vent was located directly over a raw product staging table. 6. Failure to protect against extraneous material: Dust was observed on finished product