FDA WARNING_LETTER - F. & S. Maranto, LLC - March 07, 2014

An FDA inspection of F & S Maranto, LLC, a manufacturer of ready-to-eat bread products, conducted in February and March 2014, revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110) and food labeling regulations (21 CFR 101). These violations render the firm's foods adulterated under 21 U.S.C. § 342(a)(4) and misbranded under 21 U.S.C. § 343. CGMP violations included inadequate training for food handlers, failure to minimize microbial growth or contamination (e.g., drips in the steam room), improper cleaning and sanitizing of equipment, and failure to maintain buildings (e.g., a leaking roof). Several CGMP issues were repeat observations. Labeling violations for Kaiser rolls and hearth bread included undeclared major food allergens (wheat, milk), failure to bear the common or usual name, incomplete ingredient declarations (missing sub-ingredients), absence of manufacturer/distributor name, inaccurate net quantity statements, and missing or incorrect nutrition facts. Kaiser rolls also failed to declare a chemical preservative. The FDA requires prompt corrective actions, including documentation, to address all noted violations and prevent recurrence. Failure to implement lasting corrections may result in regulatory actions like seizure or injunction, and the firm may be assessed reinspection fees. A written response outlining corrective steps is required within 15 working days.