CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated: FDA Warning Letter to Aversa's Italian Bakery, May 20, 2026

FDA Warning Letter — Violations FDA cited at Aversa's Italian Bakery

WARNING LETTER Aversa's Italian Bakery MARCS-CMS 722904 — May 20, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters 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