WARNING LETTER
Gilster-Mary Lee Corporation
MARCS-CMS 658271 —
August 28, 2023
Delivery Method:
VIA EMAIL WITH READ RECEIPT
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Thomas B. Welge
Recipient Title
President and CEO
Gilster-Mary Lee Corporation
1037 State Street
Chester
,
IL
62233
United States
twelge@gilstermarylee.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Secondary Issuing Offices
United States
WARNING LETTER
CMS 658271
August 28, 2023
Dear Mr. Welge:
The United States Food and Drug Administration (FDA) has determined that your recalled “HyVee” brand Hamburger Chili Macaroni Skillet Meal (5.2 oz. retail unit, BEST BY FEB 08 24 Y18, UPC 75450-08552), is misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product label did not declare a major food allergen, milk. The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited by section 301(a) of the Act [21 U.S.C. § 331(a)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at www.fda.gov.
On March 24, 2023, your firm recalled meals labeled HyVee brand “Hamburger Chili Macaroni Skillet Meal” that contained “Hamburger Cheeseburger Macaroni Skillet Meal” because of the presence of an undeclared milk allergen due to the use of the incorrect carton. The “Hamburger Chili Macaroni Skillet Meal” carton does not include a milk ingredient declaration, and the “Hamburger Cheeseburger Macaroni Skillet Meal” contains milk. You initiated this recall after being notified of this mislabeling by a customer. In documentation you provided to the Office of Human and Animal Food Operations (OHAFO) East 6 Recall Coordinator on April 4, 2023, you indicated that you were scheduled to run “Hamburger Cheeseburger Macaroni Skillet Meal”; however, the line supplier mistakenly brought the incorrect cartons to the production line, and the lab tech failed to verify that the correct cartons were used.
This product was manufactured and packaged on February 8, 2023, at your Gilster-Mary Lee Steeleville location, located at 10 Industrial Park Steeleville, IL 62288.
In addition, your firm has initiated three other recalls involving mislabeled products resulting in undeclared major food allergens since 2019.
On April 4, 2023, you also provided corrective and preventive control documentation, which states that you have provided re-training to employees on your firm’s procedures, and you will require production line operators for all lines to bring a carton, component, and case to the code room to be verified for every brand change. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
Misbranding
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], milk is considered a “major food allergen.” 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 parenthesis 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)].
Your HyVee “Hamburger Chili Macaroni Skillet Meal” that contained “Hamburger Cheeseburger Macaroni Skillet Meal” is 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 a major food allergen (milk).
Additional comments
Your facilities are subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule) (21 CFR Part 117). As such, you are required to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facilities will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 CFR 117.135(a)(1) and (c)(2)). The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (subparts A, C, D, E, F, and G) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, including seizure and/or injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time within which you will do so.
Your written response should be sent to Compliance Officer Daniel Arrecis, via email at Daniel.Arrecis@fda.hhs.gov. If you should have any questions regarding this letter, please contact Daniel Arrecis, Compliance Officer, at (312) 596-4263 or via email.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Foods East-Division 6
Content current as of:
03/05/2024
Regulated Product(s)
Food & Beverages