In a 2023 inspection, FDA determined that the soybean sprouts grown in a sprout and kimchi operation were adulterated as they were prepared, packed, or held under insanitary conditions. The 483 identified violations related to the sprouts section of the Produce Safety Rule, including:
- An environmental monitoring plan aimed at identifying and managing Listeria species or Listeria monocytogenes from food contact and non-food contact surfaces had not been established.
- A plan to sample and test spent-sprout irrigation water representative of production batches had not been established. Such samples are required to be tested for Salmonella species and E. coli O157:H7 as well as other relevant pathogens.
- Food contact sprout growing surfaces were not cleaned and sanitized properly before they contacted sprouts or seeds, as sanitizer was applied to unclean surfaces, and soil residues were observed on various types of equipment with which the sprouts had contact.
- Inadequate drainage and poorly maintained floors were observed.
In addition, labeling violations were observed, including a failure to properly declare food allergens on kimchi products.
The manufacturer’s failure to adequately address the violations resulted in the issuance of a warning letter, with further lack of adequate corrective action potentially subjecting the firm to legal action including, without limitation, seizure and injunction.
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