The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
St. Louis Calco LLC
Fenton, MO
The U.S. Food and Drug Administration has issued a warning letter to St. Louis Calco LLC, a Fenton, MO-based sprout operation, after finding serious violations of federal food safety regulations. The letter, dated March 21, 2024, follows FDA inspection conducted from Sept. 18-22, 2023, and Sept. 29, 2023, which revealed multiple violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, commonly known as the Produce Safety Rule (PSR).
St. Louis Calco LLC produces mung bean and soybean sprouts, which the FDA has deemed adulterated. According to the FDA, the sprouts were prepared, packed, or held under unsanitary conditions, potentially exposing consumers to harmful contaminants. The inspection also revealed that the company failed to comply with the PSR.
The inspection resulted in the issuance of a Form FDA 483. The letter highlights several specific issues that were uncovered during the inspection.
Lack of listeria monitoring plan
The FDA noted that St. Louis Calco has not implemented a written environmental monitoring plan to identify Listeria species or Listeria monocytogenes, a bacterium that can cause serious foodborne illness. Despite a previous violation during an inspection in 2019, the company has yet to establish proper monitoring protocols. Samples taken during the 2023 inspection identified Listeria monocytogenes on four of the 102 environmental swabs, including those from food contact surfaces.
While St. Louis Calco’s corrective action plan promised future environmental monitoring once a consultant is hired, the FDA criticized the lack of a written plan and expressed concerns over the company’s testing methods. The agency emphasized that proper environmental monitoring is crucial for ensuring food safety, particularly in sprout production facilities where contamination risks are high.
Inadequate sampling for sprout irrigation water
The company also failed to implement a written sampling plan to test spent sprout irrigation water (SSIW) or in-process sprouts for pathogens. According to FDA regulations, SSIW from each production batch of sprouts must be tested to ensure that it is free from contamination. The company’s current practice of collecting samples from multiple batches was deemed insufficient. St. Louis Calco was also found not to have held batches of sprouts until negative pathogen test results were confirmed.
The FDA acknowledged the company’s plans to adapt its procedures but emphasized that collecting representative samples from each production batch is necessary to ensure food safety.
Unsanitary conditions at facility
During the inspection, the FDA found multiple instances of unsanitary conditions in the facility. This included residue buildup and apparent mold growth on food contact surfaces such as growing bins, the sprout pool, and drying equipment. Investigators observed mold on the walls around the sprouts collection area and the buckets used for growing mung bean and soybean sprouts.
The FDA warned that St. Louis Calco’s current cleaning procedures, which involve the use of undiluted sanitizers, are inadequate. The agency reiterated that cleaning must be performed prior to the application of sanitizer, and pointed out that the company had failed to address similar issues during the 2019 inspection.
Concerns over water safety
St. Louis Calco’s water systems were another area of concern. The FDA reported that the company had failed to inspect its agricultural water system annually, as required by law. Investigators noted that the water storage tank used for sprout production was not fully enclosed, increasing the risk of contamination.
The company also failed to ensure that water used for sprout irrigation and cleaning met safety standards for E. coli. Despite promises to begin testing for E. coli, the FDA stated that no evidence of testing had been provided.
The full warning letter can be viewed here.
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