FDA WARNING_LETTER - Protano & Sons Inc. - December 03, 2012

The FDA conducted an inspection of Protano & Sons, Inc. from November 26 to December 3, 2012, identifying serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110) that adulterate food products (Section 402(a)(4)). Products were also misbranded under Sections 403(w) and 403(q) of the Act. CGMP deficiencies included failure to exclude pests and protect food from contamination (21 CFR 110.35(c)), inadequate pest screening (21 CFR 110.20(b)(7)), failure to prevent drip/condensate contamination (21 CFR 110.20(b)(4)), and management's failure to ensure proper employee hygienic practices (21 CFR 110.10(b)), including handwashing and appropriate attire. Misbranding issues involved Kaiser Rolls failing to declare wheat as a major allergen (Section 403(w)), and multiple products having incorrect Nutrition Facts formats (21 CFR 101.9), such as missing Trans fat declarations or incorrect 0% DV statements. Wholesale packaged bread products also lacked required labeling elements like allergen declarations, common names, ingredient lists, manufacturer details, and net quantity statements. Ingredient declarations for enriched flour and vegetable shortening were also deficient (21 CFR 101.4). The firm's December 2012 response was inadequate due to a lack of supporting documentation. Protano & Sons must respond within 15 working days with detailed corrective actions and documentation, or face potential regulatory actions like product seizure, injunction, and re-inspection fees.