Although a sprouting operation responded to the citations of the FDA 483 it received following an inspection, the FDA remained concerned about a number of areas and issued a Warning Letter with the following findings:
- The initial inspection revealed no written plan for environmental monitoring for Listeria. FDA swabs of the production environment revealed the presence of Listeria monocytogenes in the environment including from food contact surfaces. Although the firm then initiated swabbing, its plan was criticized by FDA as not comprehensive since swabs were collected immediately after sanitizing equipment and not 3 hours into production.
- The firm did not establish and implement a written sampling plan to test spent sprout irrigation water or in-process sprouts for pathogens that was comprehensive enough of each production batch.
- Food contact surfaces were not cleaned and sanitized effectively, with sanitation procedures not including cleaning steps prior to sanitizing; product residue seen on surfaces that had been cleaned; mold observed on surfaces that were rough and seemed hard to clean.
- In addition to the firm not inspecting its agricultural water systems at least once annually, it did not ensure that ag water met the standard of no detectable E. coli. FDA’s inspection also found that the water tank was not fully covered, and the water inlet did not have a proper backflow device.
