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  5. Sweet Production Inc. - 05/06/2016
  1. Warning Letters

WARNING LETTER

Sweet Production Inc.


Recipient:
Sweet Production Inc.


United States

Issuing Office:
San Francisco District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502
Telephone: (510) 337-6700
FAX: (510) 337-6703

 

Warning Letter
 
VIA OVERNIGHT DELIVERY
SIGNATURE REQUIRED
                                                                                                
May 6, 2016
 
Ms. Doreen Chin
President
Sweet Production Inc.
915 Terminal Way Ste B
San Carlos, CA 94070
FEI: 3010873774
 
Ms. Chin,
 
During an inspection of your firm located in San Carlos, CA on January 13 through January 27, 2016, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures muffins, cakes, and other bakery products. During this inspection, our Investigators found that the “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” and “Red Velvet Cake” products are not labeled in accordance with FDA’s food labeling regulations, Title 21 Code of Federal Regulations Part 101 [21 CFR 101]. These violations cause the 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 can find the Act and its implementing regulations at www.fda.gov.
 
MISBRANDING 
 
1.    Your “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” and “Red Velvet Cake” products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergens; milk, soy, eggs, and wheat as required by section 403(w)(1) of the Act.
 
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as 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 certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded 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 is adjacent to the list of ingredients as stated in 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, except that 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) as stated in section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
Specifically, according to your recipes, your “Banana Walnut Muffin,” “Red Velvet Cake,” and “Pumpkin Cream Cheese Muffin” products are manufactured using (b)(4) which contains eggs, wheat, soy, and milk; however, you fail to declare wheat, soy, eggs, and milk on your finished product labels.
 
2.    Your “Red Velvet Cake” product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product bears or contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Specifically, FD&C Red No. 3 and FD&C Red No. 40 are not declared by their listed names or appropriate abbreviations as required under 21 CFR 101.22(k)(1).
 
3.    Your “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” and “Red Velvet Cake” products are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the labels, as required by 21 CFR 101.4. Specifically, your product labels fail to include an ingredient statement on the packaged labels as required by 21 CFR 101.4(a). Ingredient information must be provided on the label of packaged food regardless of whether the customer requests it.
 
4.    Your “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” and “Red Velvet Cake” products are misbranded within meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the product labels fail to include a statement of identity as required by 21 CFR 101.3.
 
5.    Your “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” and “Red Velvet Cake” products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents as required by 21 CFR 101.105.
 
6.    Your “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” “Red Velvet Cake” product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) does not meet the requirements under 21 CFR 101.9. For example,
  • The “Red Velvet” product label fails to declare the appropriate reference amount customarily consumed (RACC) as required by 21 CFR 101.9(b)(2) and 21 CFR 101.12(b)(Table 2). Therefore, all of the nutrient values are incorrect.
  • The “Red Velvet” product label fails to declare a serving size in a household measure as required by 21 CFR 101.9(b)(1), (b)(5), and (b)(7).
  • The number of servings per container for the “Banana Walnut Muffin” and “Pumpkin Cream Cheese Muffin” are not declared in accordance with 21 CFR 101.9(b)(8)(iii). These products are not sold in single serving containers.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
    
We offer the following comment:
  • If any nutrient content claims are made for your products i.e. “low fat” and “sugar free,” the product labels must include nutrition labeling if they are served or sold to the consumer in the package in which they are received in accordance with 21 CFR 101.9(j)(2).
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 re-inspection related costs. A re-inspection 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. Re-inspection related costs mean all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the inspection and assessing and collecting the inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection 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 re-inspection-related costs.
 
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
 
Your written response should be directed to:
 
Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052
 
Refer to the Unique Identification Number CMS case 492716 when replying.
 
If you have any questions about the content of this letter please contact Ms. Lydia S. Chan, Compliance Officer at (510) 337-6776.
 
Sincerely,
/S/ 
Kathleen M. Lewis, J.D.
District Director