Tan Hung Bakery – FDA Warning Letter, Jun 28, 2011

The FDA conducted an inspection of Tan Hung Bakery's food manufacturing facility in San Francisco, California, from June 22-28, 2011. The inspection and subsequent label review revealed multiple misbranding violations under the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101.

Key violations include: - **False or Misleading Labeling:** "French Mini Bread" was misbranded because its ingredient statement listed "butter," which was not used in its manufacture (Section 403(a)(1)). - **Undeclared Major Food Allergens:** Seven products ("Sweet Roll," "Sweet Raisin Bread," "Sweet Dry Pork Bread," "French Mini Bread," "French Butter Small Breads," "Butter French Bread," and "French Small Bread") failed to declare major food allergens (eggs, milk, wheat, soy) as required by Section 403(w). - **Incorrect Common or Usual Name of Food:** "French Butter Small Bread" and "French Small Bread" packages lacked a common or usual name. "Mini French Bread" and "Sweet Roll" used the same "Sweet French Roll French Bread" label despite different formulations (Section 403(i)(1)). - **Failure to List All Ingredients and Sub-ingredients:** Several products failed to list all ingredients (e.g., margarine, eggs, corn oil, butter, high