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WARNING LETTER

Delucas Bakery Corp MARCS-CMS 710348 —

Delivery Method:
VIA ELECTRONIC DELIVERY
Product:
Food & Beverages
Recipient:
Recipient Name
Mrs. Gina L. Frank
Recipient Title
Owner
Delucas Bakery Corp

412 Kossuth St.
Riverside, NJ 08075
United States

delucasbakerynj(b)(6), (b)(7)(C)
Issuing Office:
Human Foods Program

United States

November 28, 2025

WARNING LETTER

Re: CMS #710348

Dear Mrs. Frank,

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) human food manufacturing facility, located at 412 Kossuth St. Riverside, NJ 08075 on March 25, 2025 through April 3, 2025. This inspection was initiated as a follow-up to a regulatory meeting held with your firm on September 24, 2024. During the inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Regulations (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) bakery products manufactured in your facility are adulterated within the meaning section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, 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 (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your bakery products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.

At the conclusion of the inspection, the FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your facility. As of the date of this letter, we have not received a response to the FDA-483 issued to you at the close of the inspection on April 3, 2025. After reviewing the inspectional findings, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-Based Preventive Controls Requirements (21 CFR Part 117, Subpart C)

1. You did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a)(1).

Specifically, you manufacture RTE bread products, including dinner rolls and hoagie rolls which contain major food allergens and are exposed to the environment after the baking step (pathogen control step) prior to packaging and distribution. You did not conduct a hazard analysis to identify and evaluate hazard(s) including undeclared food allergens, recontamination with environmental pathogens, and mycotoxins to determine if any require a preventive control.

a. You did not identify and evaluate undeclared allergens as a hazard requiring a preventive control. Your facility manufactures bakery products that consist of varying allergen profiles with wheat, milk, soy, egg and sesame. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR 117.135(c)(2)).

i. Regarding undeclared allergens, your RTE bread products including hoagie rolls, contain the major food allergens of wheat, milk, soy and sesame. On March 25, 2025, the hoagie rolls were observed being packed in exposed cardboard bread bins without any labeling to declare these major allergens and you do not provide your customers, who distribute the product, with an ingredient list or allergen statement.

ii. Regarding undeclared allergens, your RTE brioche bread product contains the major food allergens of wheat, milk, egg, and soy. On March 25, 2025, the product was observed being packed in clear plastic bags without any labeling to appropriately declare these major allergens. And you do not provide your customers, who further distribute the product, with an ingredient list or allergen statement.

b. You did not identify and evaluate recontamination with environmental pathogens as a known or reasonably foreseeable hazard to determine whether recontamination with environmental pathogens is a hazard requiring a preventive control, to comply with 21 CFR 117.130(c)(1)(ii).

Your facility manufactures RTE bakery products, such as hoagie and dinner rolls, that are exposed to the environment after they exit the oven (during cooling, consolidating, and packaging). The packaged foods do not receive any further lethal treatment or otherwise include a control measure that would significantly minimize the pathogen. Contamination with environmental pathogens is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Preventive controls include sanitation controls, which include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR 117.135(c)(3)).

While your firm maintains records to capture cleaning and sanitation of your mixers, coolers and proofers, you do not maintain records of sanitation monitoring for all other food contact surfaces or areas where RTE products are exposed. Additionally, your firm does not have an environmental monitoring program and you do not collect environmental swab samples to verify adequacy of cleaning and sanitation practices in your food processing environment.

This is a repeat observation from the New Jersey Department of Health (NJDOH) contract inspection conducted on April 17, 2024 through May 28, 2024 which observed that you did not have a hazard analysis along with a food safety plan.

c. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures RTE bakery products, such hoagie rolls and dinner rolls which contain wheat flour; this ingredient has been associated with mycotoxins. Contamination with mycotoxins is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control (i.e., a supply-chain control) in this ingredient. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control due to a hazard such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410). Your firm has not established a written supply-chain program to ensure that the mycotoxin hazard associated with incoming wheat flour is controlled before the ingredient arrives at your facility for use.

Current Good Manufacturing Practice Requirements (21 CFR Part 117, Subpart B)

1. You did not clean and sanitize your equipment as frequently as necessary to protect against and contamination of food as required by 21 CFR 117.35(d). Specifically, on March 26, 2025, an employee was observed utilizing a (b)(4) conveyor belt to load raw bread dough into the deck oven and then immediately unload baked RTE dinner rolls onto the same food contact surface without cleaning or sanitizing the conveyor belt in between. Additionally, the conveyor belt was not maintained to protect against contamination of food with the middle and sides of the conveyor observed to be ripped and frayed.

2. Your plant did not exclude pests from your food plant to protect against contamination of food as required by 21 CFR 117.35(c). Specifically, on March 25, 2025, an FDA Investigator observed apparent rodent droppings on a piece of unused equipment and along the baseboard of the wall in your dry ingredient storage area near where bags of wheat flour were being stored. The bags of wheat flour are subsequently used in the manufacturing of your bread products.

This is a repeat deviation from the NJDOH contract inspection conducted on April 17, 2024, through May 28, 2024, which observed that you did not prevent pests from entering your facility.

Misbranding Violations

1. Your Hoagie Rolls and Brioche Buns products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels, if any, fail to declare the major food allergens, as required by section 403(w)(1) of the Act. Specifically, your Hoagie Roll product is manufactured with wheat, milk, soy, and sesame. Your Brioche Buns without sesame product is manufactured with wheat, milk, soy, and egg. Your Brioche Buns with sesame product is manufactured with wheat, milk, soy, egg, and sesame. These major food allergens are not listed on your finished product labels.

Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines “major food allergens” as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame 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 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)].

2. Your Hoagie Rolls and Brioche Buns products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4(a). Specifically, these products are not labeled with an ingredient statement.

3. Your Brioche Buns product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label, if any, fails to bear the common or usual name of the food as required by 21 CFR 101.3.

4. Your Brioche Buns product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product fails to include the name and place of business of the manufacturer, packer, or distributor, on the product package, as required by 21 CFR 101.5(a).

5. Your Hoagie Rolls and Brioche Buns products are misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because they fail to bear an accurate statement of the net quantity of contents, as required by 21 CFR 101.7(a).

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Additional Comment

We also offer the following comment regarding your Hoagie Rolls product:

  • “Italian Bread and Rolls” is not the specific common or usual name for this product, as required in 21 CFR 101.3(b).

Please send your reply to the Food and Drug Administration, Attention: Daniel Johnson, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Daniel Johnson via email at: Daniel.Johnson@fda.hhs.gov Please include reference CMS #710348 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, J.D. M.B.A.
Acting Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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