FDA WARNING_LETTER - Yost Foods, Inc - April 24, 2019

The FDA inspected Yost Foods, Inc.'s Ready-to-Eat spice manufacturing facility in Brunswick, Ohio, from March 18 to April 24, 2019. 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).

Environmental samples collected by the FDA tested positive for *Listeria monocytogenes* (L. monocytogenes), a human pathogen. Additionally, a customer's test confirmed L. monocytogenes in the firm's aji amarillo paste, leading to a voluntary recall and destruction of the product. Whole genome sequencing linked the environmental and product strains of L. monocytogenes. These findings indicate the food is adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to implement preventive controls (21 CFR § 117.135(a)(1))**: The firm's sanitation controls for environmental pathogens were not fully implemented. Observations showed QA review occurring at an incorrect stage and inadequate rinsing documented. Repeated L. monocytogenes positives in environmental and finished product testing demonstrated ineffective sanitation. 2. **Failure to implement corrective action procedures (21 CFR 117.150(a)(1)(ii))**: Despite repeated *Listeria spp.*