Having been cited in a 483 for the lack of written plan for environmental monitoring for Listeria and FDA swabs revealing Listeria monocytogenes in the environment, including from food contact surfaces, a sprouting operation initiated a swabbing plan. However, the follow up FDA inspection elicited a warning letter because the plan was not comprehensive since swabs were collected immediately after sanitizing equipment and not three hours into production. The warning letter also noted that the firm did not establish and implement a written sampling plan to test spent sprout irrigation water or in-process sprouts for pathogens for each production batch that was comprehensive enough.
Additionally, it was found that food contact surfaces were not cleaned and sanitized effectively as sanitation procedures did not include cleaning steps prior to sanitizing, product residue was seen on surfaces that had been cleaned, and mold was observed on surfaces that were rough and seemed hard to clean; the agricultural water systems were not inspected by the firm at least once annually, the water tank was not fully covered, and the water inlet did not have a proper backflow device; and the facility did not ensure that agricultural water met the standard of no detectable E. coli.
