WARNING LETTER
Perfection Bakeries Inc., dba Aunt Millie’s Bakeries
MARCS-CMS 657559 —
September 07, 2023
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
John Popp
Recipient Title
Owner
Perfection Bakeries Inc., dba Aunt Millie’s Bakeries
350 Pearl Street
Fort Wayne
,
IN
46802
United States
jpopp@auntmillies.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Secondary Issuing Offices
United States
WARNING LETTER
CMS Case # 657559
Dear Mr. Popp:
The United States Food and Drug Administration (FDA) has determined that your recalled “Our Family” brand White Hot Dog Enriched Buns (8 count, 12oz. retail unit, UPC #0-70253-75107-3) manufactured between February 9, 2023 and March 20, 2023 are 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, sesame. 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 FDA’s requirements through links in FDA's home page at http://www.fda.gov.
Your firm recalled “Our Family” brand White Hot Dog Enriched Buns on March 21, 2023 after you discovered that the product contained sesame, but the printed packaging did not declare sesame. Your firm became aware of the undeclared sesame after being notified by a customer of an allergic reaction to sesame after a child consumed the buns. In documentation provided to the Office of Human and Animal Food Operations East Division 6 Recall Coordinator on March 21 and 28, 2023, you indicated that your firm reformulated “Our Family” brand White Hot Dog Enriched Buns in January 2023 by adding sesame to the formulation. On February 9, 2023, you received printed plastic packaging for the buns which did not declare sesame in the ingredients statement. Between February 9, 2023 and March 20, 2023, you manufactured the “Our Family” brand White Hot Dog Enriched Buns using the incorrect label, which resulted in undeclared sesame in the product.
On March 28, 2023, you provided documents which indicated that you determined the root cause to be a “lack of label control,” as the receiver accepted incorrect packaging into the plant and the bagger operator used incorrect packaging that did not contain the correct allergen labeling. You stated that your action plan includes retraining “bag operators, break people, and supervisors” to check for correct allergen labeling “before being used at point of use”; updating policy to include the “QA manager or designated back-up visually verifying and documenting every receipt of bags before they can be received in
(b)(4)
and put in the warehouse”; creating a policy that future allergen labeling changes will require a new bag number, “making it impossible to receive old bag into plant”; and creating policy that will require new packaging proofs to be signed off by your company before new packaging can be printed. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
Misbranding
As of January 1, 2023, sesame is considered a “major food allergen” under section 201(qq) of the Act [21 U.S.C. § 321(qq)]. 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)].
Your recalled “Our Family” brand White Hot Dog Enriched Buns 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 a major food allergen (sesame).
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 violation cited in this letter is 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 regulations.
You should take prompt action to correct the violation noted in this letter. Failure to promptly correct the violation 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 the violation. 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 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 firm’s response should be sent to Lauren Sexton, Compliance Officer, via e-mail at Lauren.Sexton@fda.hhs.gov. If you have any questions about this letter, please contact Lauren Sexton at (313) 393-8179 or via e-mail.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations
Division East 6
Content current as of:
02/13/2024
Regulated Product(s)
Food & Beverages