WARNING LETTER
Revolution Foods, PBC
MARCS-CMS 690586 —
April 07, 2025
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Dominic Engels
Recipient Title
CEO
Revolution Foods, PBC
5743 Smithway St, Ste 103
Commerce
,
CA
90040
United States
Issuing Office:
Human Foods Program
United States
WARNING LETTER
April 7, 2025
WL 690586
Dear Mr. Engels:
The United States Food and Drug Administration (FDA) 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 (located in Subparts A, C, D, E, F, and G of Part 117) 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].
You may find the Act and further information about FDA regulations through links on FDA's website at http://www.fda.gov.
At the conclusion of the inspection, the FDA investigators issued an FDA Form 483, Inspectional Observations (FDA 483), listing the deviations found at your facility. We received your written response to the FDA 483 via email on August 7, 2024, describing the corrective actions you have taken and plan to take. We received an updated written response on September 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. A knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control. Preventive controls for food allergens include procedures, practices, and processes employed for labeling the finished food to ensure that all food allergens are included on the label (see 21 CFR 117.135(c)(2)(ii)). Your facility does not label the individually packaged food products.
In your responses received via email on August 7, 2024 and on September 16, 2024, you stated that
(b)(4)
. You stated you
(b)(4)
.
We are unable to fully evaluate your response as you did not provide all supporting documents. For example, 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 at the
(b)(4)
steps (where RTE food is exposed to the environment prior to packaging). 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. You have written sanitation procedures (“SSOPs”) which identify cleaning and sanitizing operations for equipment and the facility. However, these procedures did not address monitoring of employee handwashing prior to donning gloves and touching RTE ingredients that they assemble into packaged meals, such as Double Cheese Torta sandwiches and Cheese Pizza Kits.
In addition, environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)). You did not have such an environmental monitoring program.
Your hazard analysis identified supply-chain control as the preventive control type for cross-contamination at your
(b)(4)
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.
In your responses received via email on August 7, 2024 and September 16, 2024, you provided an environmental monitoring program and stated that you
(b)(4)
. We cannot fully evaluate your corrections because you have not provided revised SSOPs or a Daily Pre-Operational & GMP Inspection form, to fully cover hand hygiene. Furthermore, your Environmental Monitoring Program dated August 7, 2024 does not meet the requirements in 21 CFR 117.165(b)(3) because the procedure does not identify the locations for sampling, tests conducted, and laboratory conducting the testing.
Misbranding Violations
1. Your Double Cheese Torta sandwich and Cheese Pizza Kits 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 fail to accurately declare major food allergens, as required by section 403(w)(1) of the Act. Specifically, your Double Cheese Torta sandwich products are manufactured using wheat grain Telera rolls (wheat), white pasteurized process American cheese (milk and soy) and colored pasteurized process American cheese (milk and soy), and your Cheese Pizza Kits are manufactured using mozzarella cheese (milk) and whole grain flatbread (wheat), but these ingredients are not listed on the finished product.
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)].
In your response received via email on August 7, 2024, you stated that you
(b)(4)
. However, because you package the finished food products at your facility,
(b)(4)
.
We note that all food products that are not raw agricultural commodities and are not subject to an exemption must bear appropriate allergen labeling in compliance with section 403(w) of the FD&C Act. Please verify that all food products you distribute are in compliance with the applicable labeling requirements.
2. Your Double Cheese Torta sandwich is misbranded in the following ways:
a. Within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients, and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4.
b. Within the meaning of Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to include an appropriate statement of identity in accordance with 21 CFR 101.3.
c. Within the meaning of Section 403(e)(2) [21 U.S.C. § 343(e)(2)] because the label fails to include a net quantity of contents statement in accordance with 21 CFR 101.7(a).
d. Within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
e. Within the meaning of section 403(k) of the Act because the product contains a chemical preservative but does not bear labeling stating that fact. Specifically, the product contains the preservatives sorbic acid but does not declare it, nor its function, on the finished product labels.
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. 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 and FDA regulations.
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.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 FD&C Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration via email to Elodie.Tong-Lin@fda.hhs.gov or to the U.S. Food and Drug Administration Human Foods Program, Attention: Elodie Tong-Lin, Compliance Officer, Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods (HFS-607), at 5001 Campus Drive, College Park, MD 20740 U.S.A. Please reference #690586 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Laura Akowuah, JD, MPH
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
U.S. Food and Drug Administration
Content current as of:
06/24/2025
Regulated Product(s)
Food & Beverages