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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Donuts Deluxe 9/29/11

  

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

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN  55401
Telephone: (612) 334-4100
FAX: (612) 334-4142

 

September 29, 2011


WARNING LETTER


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 11 – 58


Huy Q. Ha
Owner
Donuts Deluxe
1640 County Road E
Vadnais Heights, Minnesota  55110

Dear Mr. Ha:

An investigator from the Minneapolis District Office of the Food and Drug Administration (FDA) inspected your processing facility located at 1640 County Road E, Vadnais Heights, Minnesota, on May 23-26, 2011. Our inspection found significant deviations from the food labeling regulations, Title 21, Code of Federal Regulations (21 CFR), Part 101. These violations cause the “French Bread” distributed by your firm to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C § 343, in that it is not labeled with the mandatory information required by the Act.  You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.

Your significant violations include:

1. Your French bread product is misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the label fails to declare the major food allergen as specified by the Act.

Section 201(qq) of the Act, 21 U.S.C. 321(qq), defines as “major food allergens” 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.  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, printed immediately after or adjacent to the list of ingredient, 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 followed 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 from which the major food allergen is derived appears elsewhere in the ingredient list (unless the name of the food source is listed but not as a part of the name of an ingredient which is not required to be declared as a major food allergen), section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B).

Your French bread product is manufactured using “flour” and flour is the food prepared by grinding and bolting cleaned wheat, other than durum wheat and red durum wheat. Wheat is a major food allergen required to be declared on the product label. Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.

2. Your French bread product is misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), because ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, are not declared on your label, as required by 21 CFR 101.4(a)(1). In particular, the French bread label declares “flour;” however, based on information provided during the inspection, the flour is enriched bromated flour which contains sub-ingredients that are not declared on the finished product label in accordance with 21 CFR 101.4(b)(2).  

The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food. 

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the food labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. We may take further action if you do not promptly correct these violations.  For instance, we may take further action to seize your products and/or enjoin
your firm from operating.

Further, this letter acknowledges receipt of your letter of June 10, 2011, responding to the Form FDA-483, Inspectional Observations, issued on June 26, 2011, as a result of our inspection of your production facility. Your response has been made a part of the Minneapolis District’s permanent file for your firm. The effectiveness of the corrections you have made or will be implementing will be evaluated during the next inspection. We note that your response to item 1 addresses only the placement of the frozen eggs container on the floor of the processing room. This item should address both the placement on the floor and the thawing of product at room temperature which could allow pathogenic organisms the opportunity to grow. All frozen products should be thawed under conditions of refrigeration.

We provide the following comments:

• During our label review we noted that your French bread product does not contain the ZIP code on the label in accordance with 21 CFR 101.5(d);

• Your French bread label declares “yeast” which contains the sub-ingredients sorbitan monostearate and ascorbic acid. However, the ingredients sorbitan monostearate and ascorbic acid are not declared on the label for your French Bread as required by 21 CFR 101.4(b)(2).  

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as verification records and revised labeling, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.

Sincerely,

/s/

Gerald J. Berg
Director
Minneapolis District