FDA WARNING_LETTER - Scotty's, Inc. - August 26, 2009

The FDA conducted an inspection of Scotty's, Inc. from August 5-26, 2009, revealing insanitary conditions and violations of 21 CFR Part 110 (Current Good Manufacturing Practice) and 21 CFR Part 123 (Seafood HACCP), rendering their ready-to-eat sandwiches adulterated.

Key violations include: * **Process and Controls:** Uncovered ready-to-eat peppers stored on peeling paint shelves (21 CFR 110.80(a)(1)); refrigerated foods (turkey, ham, salad dressing, BBQ sauce) held above 45°F for extended periods (21 CFR 110.80(b)(3)(i)); deeply grooved/stained cutting boards and spatulas; ready-to-eat products in direct contact with non-food-contact surfaces; cross-contamination from unwashed knives; and repeat observations of unlined cardboard boxes for sliced bologna, racks on the floor, and racks placed on production tables (21 CFR 110.80(b)(2)). * **Equipment and Utensils:** Use of non-cleanable, poorly maintained cutting boards and spatulas (21 CFR 110.40(a)). * **Personnel:** Employees wearing unsecured jewelry (21 CFR 110.10(b)(4)); repeat