FDA WARNING_LETTER - Jansen’s Sweet Sinsations, Inc. - June 22, 2011

The FDA conducted an inspection of Jansen's Sweet Sinsations, Inc. in Mason, OH, from June 20-22, 2011. The inspection revealed significant violations, classifying the firm's packaged bread product as both misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) and adulterated under section 402(a)(4) due to Current Good Manufacturing Practice (CGMP) deficiencies (21 CFR Part 110). The misbranding violations (21 CFR Part 101) include the failure to declare the major food allergen, wheat, on the label as required by section 403(w)(1) of the Act. Additionally, the product label lacked its common or usual name (section 403(i)(1)), failed to list ingredients by common or usual name in descending order of predominance (section 403(i)(2) and 21 CFR 101.4), did not bear the name and place of business of the manufacturer, packer, or distributor (section 403(e)(1) and 21 CFR 101.5), and failed to state the net quantity of contents (section 403(e)(2) and 21 CFR 101.105). The adulteration stemmed from a CGMP violation (21 CFR 110.35(c)) where the firm failed to take effective measures to exclude pests from processing areas, with flying insects and ants observed. The owner indicated no additional steps would be taken. The FDA requires prompt written response within fifteen working days outlining specific corrective actions and documentation to prevent recurrence. Failure to comply may result in regulatory actions such as seizure or injunction.