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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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LSG Sky Chefs, Inc. 5/29/14

  

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

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Ave SE, Suite 210
Bothell, WA 98021
 
Telephone:      425-302-0340
FAX:    425-302-0402

 

May 29, 2014
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply refer to Warning Letter SEA 14-14
 
Bob Templin
Vice President of Operations, West Region
LSG Sky Chefs, Inc.
2358 South 154th Street
Seattle, Washington 98188-2038
 
WARNING LETTER
 
Dear Mr. Templin:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your airline catering facility located at 2358 South 154th Street, Seattle, Washington, on February 26, 2014, February 28, 2014, and March 3, 2014. During the inspection, a FDA investigator reviewed the labeling of your on-board meals you provide to your commercial airline customers, and found these products to be misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulations under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
 
Your on-board meals available for purchase by commercial airline passengers are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare all major food allergens present in the products, such as wheat, milk, and egg, 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 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, 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. “(wheat)”), 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) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
 
For example:
 
  • Your Roast Beef and Cheddar Baguette sandwich, prepared and packaged for United Airlines, contains Asiago baguette (which contains wheat), cheddar cheese (which contains milk), horseradish sauce (which contain egg); however, your label fails to declare the major food allergen “egg,” and the term “Dairy” cannot be used to declare the major food allergen “milk.”  Furthermore, a separate allergen declaration must be preceded by the word “Contains.”
  • Your CHZ Fruit Plate, prepared and packaged for Alaska Airlines, contains Brie and cheddar cheese (which contain milk), and crackers (which contain wheat); however, your label does not declare the allergens milk and wheat.
  • Your Fruit and Cheese Plate, prepared and packaged for American Airlines, contains cheddar, Swiss, and Muenster Cheeses (which contain milk); however, your label does not declare the allergen milk.
  • Your Roast Beef on Spiral Rye sandwich, prepared and packaged for Virgin America, contains rye bread (which contains wheat), horseradish spread (which contains egg), and cheddar cheese (which contains milk); however, your product does not declare the allergens wheat, egg, and milk.  In fact, your product does not bear any label.
  • Your Artisan Fruit and Cheese meal, prepared and packaged for Virgin America, contains Brie, pepper jack, cheddar, and Swiss cheese (which contain milk); however, your product label does not declare the allergen milk.
 
We acknowledge your response dated March 12, 2014, to the Form FDA 483, List of Inspectional Observations, issued by the investigator during the inspection. Our review of this response finds that it pertains to the Form FDA 483, List of Inspectional Observations, but also states that you will itemize the allergens for your foods sold on planes and make the information available on the boarding bill. This is not adequate as the allergen information and ingredient statement must be placed directly on the package.
 
Your on-board meals available for purchase by commercial airline passengers are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients, but the labels fail to bear a complete list of all ingredients by common or usual name, as well as all sub-ingredients, as required under 21 CFR Part 101.4. For example:
 
  • Your Roast Beef on Spiral Rye sandwich and Artisan Fruit and Cheese meal, prepared and packaged for Virgin America does not declare any ingredients, as required in 101.4(a)(1).
  • Your on-board meals are made with multi-component ingredients; however, your labels fail to declare the sub-ingredients of these ingredients in accordance with 21 CFR 101.4(b)(2).  Specifically, the following product labels fail to declare the sub-ingredients of the following multi-component ingredients:

o    Roast Beef and Cheddar Baguette sandwich, prepared and packaged for United Airlines, fails to declare the sub-ingredients for Asiago baguette, roast beef, cheddar cheese, and horseradish sauce.

o   CHZ Fruit Plate, prepared and packaged for Alaska Airlines, fails to declare the sub-ingredients for Beecher’s Flagship, Tillamook Sharp Cheddar, Brie, fresh seasonal fruit, and Partners cracker.

o    Fruit and Cheese Plate, prepared and packaged for American Airlines, fails to declare the sub-ingredients for cheddar, Swiss and Muenster Cheeses.

 
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 [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 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. 
 
Your on-board meals available for purchase by commercial airline passengers are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because there is no statement of identity on the product label, as required under 21 CFR 101.3.  Specifically, your Artisan Fruit and Cheese meal and Roast Beef on Spiral Rye sandwich that you manufacture for Virgin America does not bear a statement of identity.
 
Your on-board meals available for purchase by commercial airline passengers are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the packages do not contain the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(d).
 
Your on-board meals available for purchase by commercial airline passengers are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the packages do not provide the net quantity of contents, as required under 21 CFR 101.105.
 
The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in legal action, without further notice, including, but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
 
Additionally, we note that the sub-ingredients for the Cream Cracker used in the American Airline Fruit and Cheese Plate are not declared in accordance with 21 CFR 101.4 because the terms “vegetable fats” or “raising agents vitamins” are not the appropriate common or usual names for these sub-ingredients.
 
You should notify this office in writing, within 15 working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include documentation and any other useful information to assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
 
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 302-0415.
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director
 
 
cc: David L. Sandell, General Manager
      LSG Sky Chefs, Inc.,
      2358 South 154th Street
      Seattle, Washington 98188-2038
 
      Washington State Department of Agriculture
      Food Safety Program
      P.O. Box 42560
      Olympia, Washington 98504-2560