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  5. San Francisco Chocolate Factory, Limited Liability Corporate - 472252 - 12/08/2015
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WARNING LETTER

San Francisco Chocolate Factory, Limited Liability Corporate MARCS-CMS 472252 —

Product:
Food & Beverages
Candy/Gum (without chocolate)
Preparation & Storage
Current Good Manufacturing Practices (CGMP)

Recipient:
Recipient Name
Jay Levine
Recipient Title
President
San Francisco Chocolate Factory, Limited Liability Corporate

2045 W. Gloria Lane

Phoenix, AZ 85085
United States

Issuing Office:
Los Angeles District Office

United States


 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED                                                            
 
December 3, 2015
WL# 10-16
Jay Levine. President
San Francisco Chocolate Factory
2045 W. Gloria Lane
Phoenix, AZ 85085
                                                                                                                                               
Dear Mr. Levine:
           
The United States Food and Drug Administration (FDA) inspected your caramel and candy apple manufacturing facility, San Francisco Chocolate Factory LLC, located at 9241 N. 6th Street, Ste. 5 & 6, Phoenix, Arizona on May 14-21, 2015. FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection. To date we have not received a response from your firm to the noted observations in Form FDA-483. Based on FDA’s inspectional findings documented during the inspection, we determined that your caramel and candy apple products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.
 
Furthermore, during the inspection our investigator obtained the labels that your firm uses for your caramel candy apple products. We have reviewed the labels and found them in violation of the food labeling regulations, Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101), which causes your products to be misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. § 343]. You may find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
 
Your significant violations are as follows:
 
cGMP Violations:
 
1.    All persons working in direct contact with food components or food-contact surfaces must use hygienic practices, including washing hands thoroughly (and sanitize if necessary to protect against contamination with microorganisms) in an adequate hand-washing facility before starting work and at any time when the hands may have become soiled or contaminated, to protect against contamination of food components or food-contact surfaces, as required by 21 CFR Part 110.10(b). However, our investigator observed the following:
 
a.  A (b)(6) employee intermittently touching (b)(6) face and adjusting glasses while prepping apples and skewering them. The employee did not wash hands or change gloves after (b)(6)  hands came in contact with (b)(6) face, glasses and head before resuming work. 
 
b.  The same (b)(6) employee was observed intermittently touching (b)(6) face and scratching (b)(6) head while preparing toppings for caramel apples. The employee did not wash hands or change gloves after (b)(6) hands came in contact with (b)(6) face, glasses and head before resuming work.  
 
2.    You must conduct all food manufacturing, including packaging and storage, under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food, as required by 21 CFR Part 110.80(b)(2). However, our investigator observed a fan with accumulation of debris and dust, blowing air directly on a pot of hot caramel. Additionally, our investigator observed that the main employee restroom door and the back entrance door opens directly to the main processing area where trays of finished caramel apples in a variety of toppings were being stored uncovered.
 
Misbranded Foods
 
1.    Your “Cookies n Cream” candy apple products are misbranded within the meaning of Section 403(w) of the Act, [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen “wheat,” as required by section 403(w)(1) of the Act.
 
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as “major food allergens.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
  • The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
  • The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
Specifically, Your “Cookies n Cream” candy apple product are manufactured using (b)(4) cookies, which contain unbleached flour (wheat flour), but fail to declare the allergenic ingredient, wheat in the ingredient statement.
 
2.    Your “Cookies n Cream” and “Caramel Apple” candy apples products are misbranded under Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but their labels fail to bear the common or usual name of each ingredient, as required by 21 CFR 101.4 and fail to declare all sub-ingredients (ingredients of an ingredient in a finished product), as required by 21 CFR 101.4(b)(2). Specifically,
  • The “Cookies n Cream” product formulation includes (b)(4) cookies as an ingredient; however, the finished product label fails to declare the ingredients and sub-ingredients.
The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food [21 CFR 101.4(b)(2)]. 
  • The “Caramel Apple” products, regardless of the toppers, fail to identify which ingredients are specific to which flavor of product which is not in accordance with CPG Sec. 500.100 Bakery Products, Candy- “Catch-All” or Shotgun” Ingredient Declaration. This states, in part, the following:
Assortments in one package an all ingredients are not common to items in the assortments. 21 CFR 101.100(a)(1) permits such labeling when “in terms which are as informative as practical and which are not misleading.” In cases where such labeling is necessary, those ingredients common to all items should be listed first in the ingredient declaration followed by a listing of ingredients not common to all, including specific indications of which ingredients are actually in designated articles. Few instances will defy such organization and with the possible exception of candy assortments the statement of identity in conjunction with the ingredient declaration must enable the consumer to tell exactly what is in each articles of food.
 
The ingredients that are not common to all of the products using this packaging must be distinguishable for the specific products where it is used.
 
3.    Your “Caramel Apple” candy apple products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. For example,
  • The product labels fail to declare trans-fat as required by 21 CFR 101.9(c)(2)(ii).
  • The product labels fail to declare Vitamin A, Vitamin C, Calcium, and Iron as required by 21 CFR 101.9(d)(8). 
Nutritional information should change based on whether or not the product contains toppers and the type of topper used.
 
Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommends you review the nutrition labeling exemption in 21 CFR 101.9(j)(18) or see http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm053857.htm for more information on filing for an annual exemption.  The application may be submitted online at: https://www.accessdata.fda.gov/scripts/NLE/client/login.cfm
 
On May 22, 2015 during a conference call with our office, you promised to correct the labels immediately and add the undeclared wheat ingredient to the “Cookies n Cream” label. However, you did not provide a response or submit copies of your labels.
 
The above violations are not meant to be an all-inclusive list of violations that may exist at your facility or with respect to your products. It is your responsibility to assure that your facility and your products are in compliance with the Act, regulations for Food Labeling (21 CFR Part 101), current Good Manufacturing Practices (21 CFR Part 110), and all applicable regulations. You should take prompt action to correct all of the violations noted in this letter and to implement procedures to prevent such violations from recurring. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations cited above. You should include in your response documentation such as documents and/or procedures implemented, copies of labels for the products that your firm manufactures and distributes, or other information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, this agency expects that you will explain the reason for your delay and state when you will correct any remaining violations.
 
Please send your reply to the Food and Drug Administration, Attention: 
 
CAPT Daniel Cline, Acting Director
Compliance Branch
United States Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
If you have questions regarding this letter, please contact Marco Esteves, Compliance Officer, at 949-608-4439.
 
Additional Comments:
 
You receive your apples pre-washed from your supplier in bulk cardboard boxes. Since your apples are considered ready to eat, we recommend you purchase your apples under a supplier guarantee or certification that they have been adequately washed and free of undesirable contamination and microorganisms such as Listeria monocytogenes. We also recommend you only purchase apples from suppliers who have an environmental monitoring program and sanitation protocol to control Listeria monocytogenes contamination. You should also ensure that the apples are packaged and transported in such a way to prevent contamination during shipment to and storage at your facility. In addition, if apples become contaminated during processing at your facility (i.e. fall on floor or contact soiled surface) we recommend you discard these apples. Simply rinsing with water under the sink will not adequately eliminate contamination.  
                       
The “Caramel Apple” candy apple product label fails to include the street address of the manufacturer, packer, or distributor; however, the street address may be omitted if it is shown in a current city directory or telephone directory (21 CFR 101.5(d)).
 
 
Sincerely,
/S/ 
Steven Porter, Acting Director
Los Angeles District