JJ cake & Pastry, Corp – FDA Warning Letter, Feb 16, 2011

The FDA inspected JJ Cake & Pastry, Corp.'s facility from January 27 to February 16, 2011, uncovering serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110) that adulterated products under Section 402(a)(4) due to insanitary conditions. Several products were also misbranded (Section 403, 21 CFR Part 101) and adulterated (Section 402(c)) due to unsafe color additives. CGMP deficiencies included inadequate facility repair (e.g., dripping ceiling), production procedures causing contamination (e.g., bare hand contact with frosting), insufficient employee handwashing, improper equipment cleaning/sanitizing (e.g., rusty ice machines), inadequate equipment storage, and improper chemical storage near food. Labeling violations involved unsafe color additives (undeclared FD&C Yellow No. 5), undeclared artificial coloring, improper "0 grams Trans Fat" claims lacking disclosure statements, failure to declare all ingredients/sub-ingredients, incorrect manufacturer address, and non-compliant nutrition facts formatting (e.g., serving size, missing fatty acid declarations). Additional issues included improper allergen declarations (milk, soy), misrepresentation of characterizing flavor, incorrect nutrition information box formatting, misidentified preservative, and duplicate ingredient listings. The firm's response to the FDA-483 was incomplete, lacking evidence and sufficient detail on employee training and inspection procedures. Prompt correction is required to avoid further enforcement, such as product seizure or injunction. A detailed written response outlining specific steps, evidence, and timelines is due within fifteen working days.