FDA WARNING_LETTER - San Francisco Chocolate Factory, Limited Liability Corporate - May 21, 2015

The FDA inspected San Francisco Chocolate Factory's caramel and candy apple facility in Phoenix, AZ, from May 14-21, 2015, observing serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110) and food labeling violations (21 CFR Part 101). The firm did not respond to the issued FDA-483.

Violations include: * **CGMP Violations (Adulterated Products):** * **Hygienic Practices (21 CFR 110.10(b)):** An employee touched their face, adjusted glasses, and scratched their head while prepping apples and toppings without washing hands or changing gloves. * **Minimizing Contamination (21 CFR 110.80(b)(2)):** A dusty fan blew directly on hot caramel, and employee restroom/back entrance doors opened directly into the main processing area where uncovered finished products were stored. * **Misbranded Foods (21 U.S.C. § 343):** * **Undeclared Allergen (Section 403(w)):** "Cookies n Cream" candy apples failed to declare "wheat" (from unbleached flour in cookies) as a major food allergen. * **Missing Ingredient Information (Section 403(i)(2