WARNING LETTER
Aversa's Italian Bakery
MARCS-CMS 722904 —
May 20, 2026
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Rafael Aversa, Sr.
Recipient Title
Owner
Aversa's Italian Bakery
801 Route 168
Turnersville
,
NJ
08012-1472
United States
doughboyra@yahoo.com
Issuing Office:
Human Foods Program
United States
May 20, 2026
WARNING LETTER
Re: CMS # 722904
Dear Mr. Rafael Aversa, Sr.:
The United States Food and Drug Administration (FDA) conducted an inspection at your food manufacturing facility, Aversa's Italian Bakery, located at 801 Route 168, Turnersville, NJ 08012-1472, between August 11, 2025, and August 19, 2025. During our inspection, the investigator found significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). In addition, during the inspection, FDA collected finished product samples of steak rolls from your production facility, and the analytical results confirmed the presence of unintended sesame in this product.
Based on FDA’s inspectional findings and analytical results for samples collected from your facility, we determined that your ready-to-eat (RTE) bakery products are adulterated within the meaning of 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, B, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 USC § 331(uu)]. A label review was also conducted on your Catering Kaiser, Catering Torpedo, Kaiser Roll, and Steak Roll products which found violations of Food Labeling regulation, Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101) rendering them to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
You may find the Act and further information about FDA’s regulations through links in FDA’s home page at http://www.fda.gov.
At the conclusion of the inspection, FDA issued an FDA Form 483 (FDA-483), Inspectional Observations, listing the violations found at your facility. FDA received your firm’s emailed responses to the FDA-483 on August 27, 2025, and October 24, 2025, describing corrective actions taken by your firm. After reviewing the inspectional findings and your firm’s responses, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility. We also address your responses below.
Hazard Analysis and Risk-Based Preventive Controls Requirements (21 CFR Part 117, Subpart C)
1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). This is a repeat violation from your previous inspection. The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR § 117.126(a)(2), and your food safety plan must include the following:
1. The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
2. The written preventive controls as required by 21 CFR § 117.135(b);
3. The written supply-chain program, as required by Subpart G;
4. The written recall plan, as required by 21 CFR § 117.139(a);
5. The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
6. The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
7. The written verification procedures, as required by 21 CFR § 117.165(b).
Your facility manufactures a variety of RTE bakery products, including but not limited to Hoagie Rolls with Sesame. However, you did not have a food safety plan with the required elements for any of the products manufactured by your facility. For example, 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 (see 21 CFR § 117.130(a)). Also, you did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act (see 21 CFR § 117.135(a)(1)). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140). You must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR § 117.160). Specifically:
A. You did not identify and evaluate allergen cross-contact as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control, as required under 21 CFR § 130(b)(1)(ii). Your facility manufactures various RTE bakery products that contain allergens (such as wheat, milk, and sesame). Products containing different allergen profiles are processed on shared food-contact surfaces, shared equipment and utensils, on the same production day and with the same employees. Allergens are a known or reasonably foreseeable hazard. 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 ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and 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) and (ii)).
i. You did not have appropriate controls in place to prevent allergen cross-contact. During the inspection, our investigator observed that you make RTE bread/rolls that contain sesame on shared equipment including wooden boards, conveyor belts, and sorting tables, as bread/rolls that do not contain sesame. You did not sequence, clean, or sanitize between the sesame and non-sesame containing products. Further, on August 12, 2025, our investigator observed the following:
a. Employees failed to change gloves, wash, or sanitizer their hands between handling sesame containing hoagie rolls and non-sesame containing hoagie rolls at the sorting table.
b. Sesame containing hoagie rolls and non-sesame containing hoagie rolls were observed on the sorting table at the same time. The non-sesame containing product is not labeled as containing sesame at the finished product
(b)(4)
step.
c. Non-sesame containing dinner rolls packaged in your unlabeled bread boxes contained sesame on the bottom of the roll. This product is not labeled to contain sesame.
On August 12, 2025, FDA collected finished product samples of steak rolls from your production facility, and the analytical results confirmed the presence of unintended sesame protein at levels of
(b)(4)
ppm in this product. On October 31, 2025, you confirmed receipt of the sample results relayed to you via email on October 30, 2025.
B. You did not identify and evaluate recontamination with environmental pathogens as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control to comply with 21 CFR § 117.130(c)(1)(ii). During the inspection, RTE products were observed exposed to the environment during
(b)(4)
in the bulk bread boxes. Your firm does not conduct environmental monitoring in areas where RTE breads/rolls are exposed to the environment to verify the adequacy of your firm’s sanitation.
C. You did not identify and evaluate physical hazards such as metal as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control, as required under 21 CFR § 117.130(b)(1)(iii). During the inspection, our investigator observed that mesh metal was used for forming the raw dough on the dough forming line. The metal mesh was observed to be fraying. Further, raw dough comes into direct contact with the metal mesh and did not go through any type of metal detection.
You submitted multiple 483 responses on August 27, 2025, and October 24, 2025. While we acknowledge you submitted three prerequisite programs: an Allergen Management Policy addressing cross-contact through proper storage and dedicated sesame handling procedures, a Sanitary Operations Policy establishing master sanitation schedules and verification protocols, and a Good Manufacturing Practices Policy detailing personnel requirements and visitor controls, you did not provide a complete food safety plan with all elements required by the regulation, despite committing to completing this by October 31, 2025. Additionally, you did not provide evidence to show that your new policies have been implemented.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
1. You failed to take reasonable measures or precautions related to personnel practices as required by 21 CFR 117.10(b). This is also a repeat violation from your previous inspection.
Specifically, on August 11 and 12, 2025, our investigator observed the following:
a. Several employees were not wearing hair nets while handling products being packaged.
b. Employees' personal beverages were observed in production areas.
c. Several employees were handling raw dough and in-process products while wearing jewelry including earrings and necklaces, as well as wireless headphones.
Furthermore, you did not have records available to document that your employees have received food hygiene and food safety training.
Misbranding Violations
1. Your Catering Kaiser and Kaiser Roll products 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 (milk). Specifically, your Catering Kaiser and Kaiser Roll products packaged in plastic bags are manufactured with whey, but the label does not list the major food allergen milk. 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 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 Catering Kaiser, Catering Torpedo, Kaiser Roll, and Steak Roll products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false and misleading. Specifically, the net quantity of contents statements is inconsistent with the serving size and servings per container. The same plastic bag label is used for the Catering Kaiser and Catering Torpedo products declared “TOTAL WT. 12 OZ”. Also, the same plastic bag label is used for the Kaiser Roll and Steak Roll products declared “TOTAL WT. 1 LB 5 OZ (21 OZS)”. Based on the Nutrition Facts Label (NFL) serving information:
Catering Kaiser: 12 servings x 57g = 684g (approximately 24 oz)
Catering Torpedo: 12 servings x 57g = 684g (approximately 24 oz)
Kaiser Roll: 12 servings × 57g = 684g (approximately 24 oz)
Steak Roll: 6 servings × 85g = 510g (approximately 17-18 oz)
For the Catering Kaiser and Catering Torpedo products, the product weight determined from the servings per container and serving size declared in the NFL is inconsistent with the declared weight of 12 OZ. Also, for the Kaiser Roll and Steak Roll products, the product weight determined from the servings per container and serving size declared in the NFL is inconsistent with the declared weight of 1 LB 5 OZ (21 OZS).
3. Your Kaiser Roll and Steak Roll products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Label) does not meet the requirements in 21 CFR 101.9. For example, mandatory nutrients such as added sugars, vitamins and minerals such as vitamin D and potassium are not declared as required in 21 CFR 101.9(c), and the footnote is not in accordance with 21 CFR 101.9(d)(9).
4. Your Catering Kaiser and Kaiser Roll 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. Specifically, during the inspection, our investigator was informed that the same ingredients were used for all your products. The dough formulation includes the ingredient whey, but it is not declared in the ingredient statement for the Catering Kaiser and Kaiser Roll products. According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “subingredients”) 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.
We also note that the Steak Roll and Catering Torpedo products’ ingredient lists are inconsistent with the Kaiser Roll and Catering Kaiser products. Specifically, the Steak Roll and Catering Torpedo products’ ingredient lists do not include the ingredients defatted soy flour and soy lecithin.
5. Your Steak Rolls, Kaiser Rolls, Catering Kaiser, and Catering Torpedo products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that they fail to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(a).
The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or 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 that your firm complies with all requirements of federal law, including applicable FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
In addition to the violations above, we provide the following comments:
You have failed to register your food facility as required by 21 CFR § 1.225 under the Bioterrorism Act and Food Safety Modernization Act. You must complete your facility registration immediately to comply with federal requirements.
We note that your firm uses exposed cardboard bread boxes to hold and transport various types of products, including Hoagie Rolls (with and without sesame seeds), Dinner Rolls, and Kaiser Rolls products, which do not include label information, except for the name of the business. During the inspection, you informed our investigator that you would begin placing stickers on the cardboard bread boxes to have an ingredient list and contains statement for allergens, and that you would change the bread boxes at the next printing. We encourage that the information on the bread boxes should be consistent with the information on the retail packages.
We note that the Catering Kaiser and Catering Torpedo products share the same label listing both products’ NFL and ingredient list. Similarly, the Kaiser Roll and Steak Roll products also share the same label listing both products’ NFL and ingredient list. The names of the products are located on the information panel. In accordance with 21 CFR 101.3(a), the statement of identity must be on the principal display panel. While the nature of the product is apparent through the clear packaging, we question whether “Catering Kaiser” and “Catering Torpedo” are appropriate statements of identity in accordance with 21 CFR 101.3(b).
Your Catering Kaiser, Catering Torpedo, Kaiser Roll, and Steak Roll products are missing the words “Net Weight” in accordance with 21 CFR 101.7(j)(3).
Please notify FDA in writing within fifteen (15) working days of receipt of this letter, of the specific steps and corrections 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 fifteen (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.
Please send your reply to HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Liza Quiles, Compliance Office, at Liza.Quiles@fda.hhs.gov or by hard copy to the Food and Drug Administration, Attention: Liza Quiles, 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 this letter, you may contact Liza Quiles, Compliance Officer via email at: Liza.Quiles@fda.hhs.gov. Please reference #722904 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Maria S. Knirk, JD MBA
Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
06/02/2026
Regulated Product(s)
Food & Beverages