From the Letter
- "Specifically, your food safety plan identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard, but you did not fully implement your “Sanitation Standard Operating procedure (SSOP), We also gathered documentation that one of your customers tested and found your aji amarillo paste to be positive for L. monocytogenes."
- "In addition, a review of records of your weekly environmental monitoring program for Listeria spp. shows that (b)(4). (b)(4) collected by FDA during our most recent inspection were positive for L. monocytogenes. Furthermore, your finished aji amarillo paste product was found to be positive for L. monocytogenes (b)(4)."
- "Whole genome sequencing analysis showed the L. monocytogenes isolates from the environmental swabs collected by FDA were the same strain as that in the finished product aji amarillo paste tested by your customer. Your environmental testing results and these findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent the hazard of L. monocytogenes in your facility"
- "You did not implement your written corrective action procedures to address the presence of an environmental pathogen or appropriate indicator organism detected through your environmental monitoring, as required by 21 CFR 117.150(a)(1)(ii). Specifically, in your food safety plan, you identified (b)(4). (Environmental monitoring is a verification activity for preventive controls as reflected in 21 CFR 117.165(a)(3).) Your environmental monitoring program lists the following corrective actions after a presumptive positive for Listeria spp.: (b)(4). Your weekly environmental monitoring program for Listeria spp. (b)(4). Each time, your corrective actions were limited to (b)(4). You did not perform an investigation to locate a potential source of contamination or make any changes to your sanitation practices."
- "You did not clean and sanitize utensils and equipment in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). On March 28, 2019, our investigator observed an employee using a high-pressure hose to spray the mezzanine floor with water while performing sanitation operations. Water overspray created a mist surrounding the open medium ribbon blender used to manufacture aji amarillo paste. On April 2, 2019, our investigator observed water overspray around the blue (b)(4) pallets on which employees were cleaning product transfer hoses, (b)(4) blades, a (b)(4), (b)(4) hopper, and (b)(4) fixtures used in the manufacture of the aji amarillo paste. Our investigator also observed an employee cleaning a product transfer pipe without cleaning the full interior of the pipe."
FDA Warning letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yost-foods-inc-581473-09102019
Yost Foods, Inc
MARCS-CMS 581473 — September 10, 2019
