FDA WARNING_LETTER - Revolution Foods, PBC - July 17, 2024

On April 7, 2025, the FDA issued a Warning Letter to Revolution Foods, PBC, following an inspection from June 26, 2024, to July 17, 2024, at their Commerce, CA facility, where they manufacture ready-to-eat (RTE) packaged foods like cheese pizzas and sandwiches.

The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), and significant violations of food labeling regulations (21 CFR Part 101), causing products to be misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Hazard Analysis Deficiencies (21 CFR 117.130(a)(1)):** Failure to identify undeclared allergens as a hazard requiring a preventive control, despite manufacturing products with different allergenic profiles (milk, soy, wheat) and distributing them without ingredient or allergen declarations. The company's responses were deemed insufficient due to a lack of supporting documentation, including a revised Hazard Analysis and updated allergen preventive control procedures. 2. **Sanitation Preventive Control Deficiencies (21 CFR 117.135(c)(3)):** Written sanitation procedures did not address monitoring employee handwashing before handling RTE ingredients. Additionally