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WARNING LETTER
•Shun Fung International Trading Inc.•April 7, 2010

FDA WARNING_LETTER - Shun Fung International Trading Inc. - April 07, 2010

Record Details

The FDA conducted an inspection of Shun Fung International Trading, Inc. d/b/a Yummy Food Co.'s food manufacturing facility in San Francisco, CA, from March 31 to April 7, 2010. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), leading to products being deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key CGMP deficiencies included failure to handle equipment to prevent contamination (e.g., strainers on the floor, roasting trays on garbage cans), inadequate employee hygienic practices (e.g., gloved hands touching floors then food, not changing gloves), failure to confine beverage drinking, improper storage of toxic cleaning compounds near food, and insufficient space for sanitary operations and pest monitoring. Additionally, the firm's Yummy Food Co. brand Cup Cake and Roasted Peanut products were found to be misbranded under section 403(q) and 403(w) of the Act, violating 21 CFR Part 101. Labeling issues for the Cup Cake product included missing nutrition facts information (trans fat, %DV for fiber), incorrect serving size, and unauthorized abbreviations. Both Cup Cake and Roasted Peanut labels had undeclared major food allergens (though revised labels addressed this), undeclared ingredients (e.g., "Cream Cake Mix" components), numeric designations as intervening material, incomplete firm addresses, and numerous spelling/punctuation errors. The "Roasted Peanut" product's statement of identity was also questioned due to soybean curd content. The FDA requires a written response within fifteen working days outlining specific corrections, including documentation like new labels, with potential further action such as product seizure or injunction if violations are not promptly corrected.

Company
Shun Fung International Trading Inc.
Inspection date
April 7, 2010
Product type
Devices
Office
Department of Health and Human Services
Person
  • Barbara J. Cassens (Director )
View Company Profile

ID · 5589a9ad-c00f-4fb9-8910-be2c245904dd

Violation Codes10
21 CFR 11021 U.S.C. 342(a)(4)21 U.S.C. 343(q)21 U.S.C. 343(w)21 CFR 110.80(b)(7)21 CFR 110.10(b)21 CFR 110.10(b)(5)21 CFR 110.10(b)(8)21 CFR 110.35(b)(2)21 CFR 110.10(b)(9)

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