As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts portions of warning letters to protect companies.
Revolution Foods PBC
Commerce, CA
The Food and Drug Administration inspected your manufacturing facility, where you manufacture ready-to-eat (RTE) packaged food products including cheese pizzas and cheese sandwiches, located at 5743 Smithway St, Ste 103, Commerce, CA, 90040 from June 26, 2024 through July 17, 2024. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 Part CFR 117). 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 is prohibited by section 301(uu) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 331(uu)]. In addition, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your Double Cheese Torta sandwich and Cheese Pizza Kits products to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
At the conclusion of the inspection, the FDA investigators issued an FDA Form 483, Inspectional Observations listing the deviations found at your facility. We received your written response to the FDA 483 via email on Aug. 7, 2024, describing the corrective actions you have taken and plan to take. We received an updated written response on Sept. 16, 2024. After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We also address the details of your response below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR 117 Subpart C):
1. You did not appropriately evaluate all known or reasonably foreseeable hazards to determine whether there are hazards requiring a preventive control for your RTE packaged food products such as cheese pizzas and cheese sandwiches, as required by 21 CFR 117.130(a)(1).
Specifically, your hazard analysis for “Ready to Eat: Hot & Cold Entrees, Wraps, Salads, Snacks and Beverages” evaluated the hazard of undeclared allergens due to incorrect labels at the packaging and labeling application step but did not identify it as a hazard requiring a preventive control and did not include any rationale for not doing so. Your facility manufactures packaged food products containing different allergenic profiles, such as your Double Cheese Torta sandwich (milk, soy, and wheat) and Cheese Pizza Kits (milk, soy, and wheat). They are distributed to schools and school districts with labeling that does not include an ingredient statement and allergen declaration. Undeclared allergens are a known or reasonably foreseeable hazard. Your facility does not label the individually packaged food products.
You have not provided a revised Hazard Analysis demonstrating that you have identified the hazard of undeclared allergens due to incorrect labels as a hazard requiring a preventive control, nor have you provided an updated allergen preventive control procedure; additionally you do not intend to declare allergens on the individually packaged products that you distribute to schools, school districts, senior care facilities, and seniors through home delivery services.
2. Your written sanitation preventive controls did not 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, as required by 21 CFR 117.135(c)(3).
Specifically, your hazard analysis for “Ready to Eat: Hot & Cold Entrees, Wraps, Salads, Snacks and Beverages” identified contamination with vegetative pathogens (cross-contamination) as a hazard requiring a preventive control. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.
Your hazard analysis identified supply chain control as the preventive control type for cross-contamination at your (redacted) steps. However, a supply chain applied control means a preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt; see 21 CFR 117.3. Therefore, please note that a supply-chain program is not an appropriate preventive control type for hazards associated with operations in your own facility, such as contamination with environmental pathogens during your manufacturing of RTE meals.
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure or injunction.
(To sign up for a free subscription to Food Safety News, click here)
