FDA WARNING_LETTER - Pastry Food Products, Inc. - June 15, 2011

The FDA conducted an inspection of Pastry Food Products, Inc. from June 7-15, 2011, revealing serious violations of Current Good Manufacturing Practices (CGMP) (21 CFR Part 110) and misbranding under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4) and § 343).

CGMP violations include: 1. Dough contamination from an employee's soiled apron and the floor (21 CFR 110.80). 2. Employee failing to wear a beard cover while handling dough (21 CFR 110.10(b)(6)). 3. Lack of hot running water at sinks in restrooms and the manufacturing area for cleaning and handwashing (21 CFR 110.37(a)). 4. Absence of protective shields on fluorescent lamps over exposed food in manufacturing areas (21 CFR 110.20(b)(5)). 5. Distribution of refrigerated products in a non-refrigerated van for up to 1.5 hours (21 CFR 110.93).

Labeling violations for "Trigal Pastelillos Coctel de Pizza," "Trigal Empanadillas Sabor a Carne," and "Trigal Plantillas Coctel para Pastelillos y