FDA EIR - Living Tree Community Foods - September 05, 2024

An FDA inspection of Living Tree Community Foods, a manufacturer of tree nut and seed butters in Berkeley, CA, was conducted from August 13 to September 5, 2024. This comprehensive inspection served as a follow-up to a Warning Letter issued on March 4, 2024, and assessed compliance with 21 CFR Part 117 (Preventive Controls for Human Food) and 21 CFR Part 101 (Food Labeling). The inspection revealed significant violations. The company's written supply-chain program was found inadequate to ensure hazards, particularly pathogens like Salmonella and E. coli in raw materials (e.g., cashews, sesame, walnuts), were significantly minimized or prevented. Issues included a lack of documentation for raw material manufacturers, expired supplier audit certificates, and no verified "kill steps" for pathogens. Furthermore, the firm failed to properly implement sanitation monitoring, corrective action, and verification procedures. This was evidenced by visible sesame allergen residue on equipment after cleaning, indicating a risk of cross-contact when changing production to other nuts. The hazard analysis also remained deficient in identifying all necessary preventive controls. These findings echo issues from the previous 2023 inspection, which led to the Warning Letter. Previous citations included inadequate hazard analysis, insufficient equipment cleaning, and poor personnel practices, alongside drug claims and labeling violations. Living Tree Community Foods has committed to providing a written response within 15 business days to address the current observations. The FDA cautioned that failure to correct these serious conditions could result in legal sanctions such as seizure, injunction, or civil penalties.