Gloria's Pantry – FDA Warning Letter, Feb 2, 2011

On June 3, 2011, the FDA issued a Warning Letter to Gloria's Pantry following an inspection from January 13 to February 2, 2011. The inspection revealed serious violations of 21 CFR Part 110 (CGMP regulations) and found *Listeria monocytogenes* on a direct food contact surface (a plastic bowl used for lettuce). This rendered the facility's products adulterated under 21 U.S.C. § 342(a)(4).

Specific violations included: 1. Failure to maintain food contact surfaces to prevent contamination (21 CFR 110.40(a)): A cracked, taped plastic bowl, contaminated with *L. monocytogenes*, was used for lettuce. 2. Failure to maintain sanitary buildings and facilities (21 CFR 110.35(a)): Packing tables, floors, and walls had food debris; cobwebs were over food preparation areas. 3. Failure to ensure hygienic practices by employees (21 CFR 110.10(b)): Employees handled food with exposed rings, nail polish, and street clothes; personal items were stored near food; an employee ate while preparing food; and no hair restraints were worn. 4. Failure to protect in-process food from contamination (21 CFR 110.80(b)(5)): Un